Data transmission schemes for a medical system, monitor device for a medical appliance and related methods

ABSTRACT

The present disclosure provides a monitor device for an ostomy system, the monitor device comprising: a processor; memory; a first interface connected to the processor and the memory, the first interface configured for connecting to an ostomy appliance; and a second interface comprising a transceiver connected to the processor for transmitting monitor data according to a transmission scheme. The second interface is configured for connecting to one or more accessory devices. The processor comprises a transmission controller configured to control the transmission scheme, wherein to control the transmission scheme comprises applying a primary transmission scheme or a secondary transmission scheme different from the primary transmission scheme.

The present disclosure relates to an ostomy system, devices thereof and method for monitoring an ostomy appliance. The ostomy appliance system comprises an ostomy appliance and an ostomy monitor device. In particular, the present disclosure relates to data transmission schemes of a monitor device for an ostomy appliance.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings are included to provide a further understanding of embodiments and are incorporated into and a part of this specification. The drawings illustrate embodiments and together with the description serve to explain principles of embodiments. Other embodiments and many of the intended advantages of embodiments will be readily appreciated as they become better understood by reference to the following detailed description. The elements of the drawings are not necessarily to scale relative to each other. Like reference numerals designate corresponding similar parts.

FIG. 1 illustrates an exemplary ostomy system,

FIG. 2 illustrates an exemplary monitor device of the ostomy system,

FIG. 3 is an exploded view of a base plate of an ostomy appliance,

FIG. 4 is an exploded view of an exemplary electrode assembly,

FIG. 5 is a proximal view of parts of a base plate,

FIG. 6 is a distal view of an exemplary electrode configuration,

FIG. 7 is a distal view of an exemplary masking element,

FIG. 8 is a distal view of an exemplary first adhesive layer,

FIG. 9 is a proximal view of the first adhesive layer of FIG. 8,

FIG. 10 is a distal view of a part of the base plate including monitor interface,

FIG. 11 is a block diagram illustrating an exemplary monitor device of the ostomy system according to the present disclosure,

FIG. 12 illustrates a flow diagram of a method of monitoring an ostomy appliance with a monitor device according to the present disclosure,

FIG. 13 is an exemplary graphical representation of parameter data as a function of time,

FIG. 14 is an exemplary graphical representation of parameter data as a function of time,

FIG. 15 is an exemplary graphical representation of parameter data as a function of time,

FIG. 16 is an exemplary graphical representation of parameter data as a function of time and a whitening zone diameter as a function of time, and

FIGS. 17A-17B are exemplary graphical representations of peel force as a function of a peeling distance travelled by a peeling action exercising the peel force on a first adhesive layer of a base plate.

DETAILED DESCRIPTION

Various exemplary embodiments and details are described hereinafter, with reference to the figures when relevant. It should be noted that the figures may or may not be drawn to scale and that elements of similar structures or functions are represented by like reference numerals throughout the figures. It should also be noted that the figures are only intended to facilitate the description of the embodiments. They are not intended as an exhaustive description of the invention or as a limitation on the scope of the invention. In addition, an illustrated embodiment needs not have all the aspects or advantages shown. An aspect or an advantage described in conjunction with a particular embodiment is not necessarily limited to that embodiment and can be practiced in any other embodiments even if not so illustrated, or if not so explicitly described.

Throughout this disclosure, the words “stoma” and “ostomy” are used to denote a surgically created opening bypassing the intestines or urinary tract system of a person. The words are used interchangeably, and no differentiated meaning is intended. The same applies for any words or phrases derived from these, e.g. “stomal”, “ostomies” etc. Also, the solid and liquid wastes emanating from the stoma may be referred to as both stomal “output,” “waste(s),” and “fluids” interchangeably. A subject having undergone ostomy surgery may be referred to as “ostomist” or “ostomate”—moreover, also as “patient” or “user”. However, in some cases “user” may also relate or refer to a health care professional (HCP), such as a surgeon or an ostomy care nurse or others. In those cases, it will either be explicitly stated, or be implicit from the context that the “user” is not the “patient” him- or herself.

In the following, whenever referring to proximal side or surface of a layer, an element, a device or part of a device, the referral is to the skin-facing side or surface, when a user wears the ostomy appliance. Likewise, whenever referring to the distal side or surface of a layer, an element, a device or part of a device, the referral is to the side or surface facing away from the skin, when a user wears the ostomy appliance. In other words, the proximal side or surface is the side or surface closest to the user, when the appliance is fitted on a user and the distal side is the opposite side or surface—the side or surface furthest away from the user in use.

The axial direction is defined as the direction of the stoma, when a user wears the appliance. Thus, the axial direction is generally perpendicular to the skin or abdominal surface of the user.

The radial direction is defined as perpendicular to the axial direction. In some sentences, the words “inner” and “outer” may be used. These qualifiers should generally be perceived with respect to the radial direction, such that a reference to an “outer” element means that the element is farther away from a centre portion of the ostomy appliance than an element referenced as “inner”. In addition, “innermost” should be interpreted as the portion of a component forming a centre of the component and/or being adjacent to the centre of the component. In analogy, “outermost” should be interpreted as a portion of a component forming an outer edge or outer contour of a component and/or being adjacent to that outer edge or outer contour.

The use of the word “substantially” as a qualifier to certain features or effects in this disclosure is intended to simply mean that any deviations are within tolerances that would normally be expected by the skilled person in the relevant field.

The use of the word “generally” as a qualifier to certain features or effects in this disclosure is intended to simply mean—for a structural feature: that a majority or major portion of such feature exhibits the characteristic in question, and—for a functional feature or an effect: that a majority of outcomes involving the characteristic provide the effect, but that exceptionally outcomes do no provide the effect.

The present disclosure relates to an ostomy system and devices thereof, such as an ostomy appliance, a base plate for an ostomy appliance, a monitor device, and optionally one or more accessory devices. Further, methods related to the ostomy system and devices thereof are disclosed. An accessory device (also referred to as an external device) may be a mobile phone or other handheld device. An accessory device may be a personal electronic device, e.g. a wearable, such as a watch or other wrist-worn electronic device. An accessory device may be a docking station. The docking station may be configured to electrically and/or mechanically couple the monitor device to the docking station. The docking station may be configured for charging the monitor device and/or configured for transferring data between the monitor device and the docking station. The ostomy system may comprise a server device. The server device may be operated and/or controlled by the ostomy appliance manufacturer and/or a service centre.

The present disclosure provides an ostomy system and devices thereof, such as an ostomy appliance, a base plate for an ostomy appliance, a monitor device, and optionally one or more accessory devices which either alone or together facilitate reliable determination of the nature, severity and rapidness of moisture propagation in the adhesive material provided for attaching the base plate to the skin surface of a user. Depending on the nature of the pattern of moisture propagation in the adhesive, the ostomy system and devices thereof enable providing information to the user about the type of failure, and in turn enable providing an indication to the user of the severity and thus the remaining time frame for replacing the ostomy appliance without experiencing severe leakage and/or skin damage.

The ostomy appliance comprises a base plate and an ostomy pouch (also referred to as an ostomy bag). The ostomy appliance may be a colostomy appliance, an ileostomy appliance or a urostomy appliance. The ostomy appliance may be a two-part ostomy appliance, i.e. the base plate and the ostomy pouch may be releasably coupled e.g. with a mechanical and/or an adhesive coupling, e.g. to allow that a plurality of ostomy pouches can be utilized (exchanged) with one base plate. Further, a two-part ostomy appliance may facilitate correct application of the base plate to skin, e.g. to an improved user sight of the stomal region. The ostomy appliance may be a one-part ostomy appliance, i.e. the base plate and the ostomy pouch may be fixedly attached to each other. The base plate is configured for coupling to a user's stoma and/or skin surrounding the stoma, such as a peristomal skin area.

The base plate comprises a first adhesive layer, also denoted center adhesive layer. During use, the first adhesive layer adheres to the user's skin (peristomal area) and/or to additional seals, such as sealing paste, sealing tape and/or sealing ring. Thus, the first adhesive layer may be configured for attachment of the base plate to the skin surface of a user. The first adhesive layer may have a stomal opening with a center point.

The first adhesive layer may be made of a first composition. The first composition may comprise one or more polyisobutenes and/or styrene-isoprene-styrene. The first composition may comprise one or more hydrocoloids.

The first composition may be a pressure sensitive adhesive composition suitable for medical purposes comprising a rubbery elastomeric base and one or more water soluble or water swellable hydrocolloids. The first composition may comprise one or more polybutenes, one or more styrene copolymers, one or more hydrocolloids, or any combination thereof. The combination of the adhesive properties of the polybutenes and the absorbing properties of the hydrocolloids renders the first composition suitable for use in ostomy appliances. The styrene copolymer may for example be a styrene-butadiene-styrene block copolymer or a styrene-isoprene-styrene block copolymer. Preferably, one or more styrene-isoprene-styrene (SIS) block type copolymers are employed. The amount of styrene block-copolymer may be from 5% to 20% of the total adhesive composition. The butene component is suitably a conjugated butadiene polymer selected from polybutadiene, polyisoprene. The polybutenes are preferably present in an amount of from 35-50% of the total adhesive composition. Preferably, the polybutene is polyisobutylene (PIB). Suitable hydrocolloids for incorporation in the first composition are selected from naturally occurring hydrocolloids, semisynthetic hydrocolloids and synthetic hydrocolloids. The first composition may comprise 20-60% hydrocolloids. A preferred hydrocolloid is carboxymethylcellulose (CMC). The first composition may optionally contain other components, such as fillers, tackifiers, plasticizers, and other additives.

The first adhesive layer may have a plurality of sensor point openings. A sensor point opening of the first adhesive layer is optionally configured to overlap a part of an electrode, e.g. to form a sensor point.

The sensor point openings of the first adhesive layer may comprise primary sensor point openings. The primary sensor point openings may comprise one or more primary first sensor point openings and one or more primary second sensor point openings, the primary first sensor point openings configured to overlap parts of an electrode and the primary second sensor point openings configured to overlap parts of another electrode different from the electrode at least partly overlapped by the primary first sensor point openings.

The sensor point openings of the first adhesive layer may comprise secondary sensor point openings. The secondary sensor point openings may comprise one or more secondary first sensor point openings and one or more secondary second sensor point openings, the secondary first sensor point openings configured to overlap parts of an electrode and the secondary second sensor point openings configured to overlap parts of another electrode different from the electrode at least partly overlapped by the secondary first sensor point openings.

The sensor point openings of the first adhesive layer may comprise tertiary sensor point openings. The tertiary sensor point openings may comprise one or more tertiary first sensor point openings and one or more tertiary second sensor point openings, the tertiary first sensor point openings configured to overlap parts of an electrode and the tertiary second sensor point openings configured to overlap parts of another electrode different from the electrode at least partly overlapped by the tertiary first sensor point openings.

The first adhesive layer may have a substantially uniform thickness. The first adhesive layer may have a thickness in the range from 0.1 mm to 1.5 mm, e.g. in the range from 0.2 mm to 1.2 mm.

The first adhesive layer may have a primary thickness in a primary part of the first adhesive layer, e.g. in a primary region within a primary radial distance or in a primary radial distance range from the center point of the stomal opening. The primary thickness may be in the range from 0.2 mm to 1.5 mm. such as about 1.0 mm. The primary radial distance may be in the range from 20 mm to 50 mm, such as in the range from 25 mm to 35 mm, e.g. 30 mm.

The first adhesive layer may have a secondary thickness in a secondary part of the first adhesive layer, e.g. in a secondary region outside a secondary radial distance or in a secondary radial distance range from the center point of the stomal opening. The secondary thickness may be in the range from 0.2 mm to 1.0 mm, such as about 0.5 mm. The secondary radial distance may be in the range from 20 mm to 50 mm, such as in the range from 25 mm to 35 mm, e.g. 30 mm.

The base plate may comprise a second layer. The second layer may be an adhesive layer, also denoted rim adhesive layer. The second layer may have a second radial extension that is larger than a first radial extension of the first adhesive layer at least in a first angular range of the base plate. Accordingly, a part of a proximal surface of the second layer may be configured for attachment to the skin surface of a user. The part of a proximal surface of the second layer configured for attachment to the skin surface of a user is also denoted the skin attachment surface of the second adhesive layer. The second layer may have a stomal opening with a center point.

The second adhesive layer may be made of a second composition. The second composition may comprise one or more polyisobutenes and/or styrene-isoprene-styrene. The second composition may comprise one or more hydrocoloids.

The second composition may be a pressure sensitive adhesive composition suitable for medical purposes comprising a rubbery elastomeric base and one or more water soluble or water swellable hydrocolloids. The second composition may comprise one or more polybutenes, one or more styrene copolymers, one or more hydrocolloids, or any combination thereof. The combination of the adhesive properties of the polybutenes and the absorbing properties of the hydrocolloids renders the second composition suitable for use in ostomy appliances. The styrene copolymer may for example be a styrene-butadiene-styrene block copolymer or a styrene-isoprene-styrene block copolymer. Preferably, one or more styrene-isoprene-styrene (SIS) block type copolymers are employed. The amount of styrene block-copolymer may be from 5% to 20% of the total adhesive composition. The butene component is suitably a conjugated butadiene polymer selected from polybutadiene, polyisoprene. The polybutenes are preferably present in an amount of from 35-50% of the total adhesive composition. Preferably, the polybutene is polyisobutylene (PIB). Suitable hydrocolloids for incorporation in the second composition are selected from naturally occurring hydrocolloids, semisynthetic hydrocolloids and synthetic hydrocolloids. The second composition may comprise 20-60% hydrocolloids. A preferred hydrocolloid is carboxymethylcellulose (CMC). The second composition may optionally contain other components, such as fillers, tackifiers, plasticizers, and other additives.

Different ratio of contents may change properties of the first and/or second adhesive layers. The second adhesive layer and the first adhesive layer may have different properties. The second adhesive layer (second composition) and the first adhesive layer (first composition) may have different ratios of polyisobutenes, styrene-isoprene-styrene, and/or hydrocoloids. For example, the second adhesive layer may provide a stronger attachment to the skin compared to attachment to the skin provided by the first adhesive layer. Alternatively, or additionally, the second adhesive layer may be thinner than the first adhesive layer. Alternatively, or additionally, the second adhesive layer may be less water and/or sweat absorbing than the first adhesive layer. Alternatively, or additionally, the second adhesive layer may be less mouldable than the first adhesive layer. The second adhesive layer may provide a second barrier against leakage.

The second layer may have a substantially uniform thickness. The second layer may have a thickness in the range from 0.1 mm to 1.5 mm, e.g. in the range from 0.2 mm to 1.0 mm, such as 0.5 mm, 0.6 mm, or 0.7 mm.

The base plate comprises one or more electrodes, such as a plurality of electrodes, such as two, three, four, five, six, seven or more electrodes. The electrodes, e.g. some or all the electrodes, may be arranged between the first adhesive layer and the second adhesive layer. The electrodes may be arranged in an electrode assembly, e.g. an electrode layer. An electrode comprises a connection part for connecting the electrodes to other components and/or interface terminals. An electrode may comprise one or more conductor parts and/or one or more sensing parts. The electrode assembly may be arranged between the first adhesive layer and the second adhesive layer. The base plate, e.g. the electrode assembly, may comprise a first electrode, a second electrode and optionally a third electrode. The base plate, e.g. the electrode assembly, may comprise a fourth electrode and/or a fifth electrode. The base plate, e.g. the electrode assembly, optionally comprises a sixth electrode. The base plate, e.g. the electrode assembly, may comprise a ground electrode. The ground electrode may comprise a first electrode part. The first electrode part of the ground electrode may form a ground for the first electrode. The ground electrode may comprise a second electrode part. The second electrode part of the ground electrode may form a ground for the second electrode. The ground electrode may comprise a third electrode part. The third electrode part of the ground electrode may form a ground for the third electrode. The ground electrode may comprise a fourth electrode part. The fourth electrode part of the ground electrode may form a ground for the fourth electrode and/or the fifth electrode.

The ground electrode or electrode parts of the ground electrode may be configured as or form a (common) reference electrode for some or all of the other electrodes of the electrode assembly. The ground electrode may also be denoted reference electrode.

The electrodes are electrically conductive and may comprise one or more of metallic (e.g. silver, copper, gold, titanium, aluminium, stainless steel), ceramic (e.g. ITO), polymeric (e.g. PEDOT, PANI, PPy), and carbonaceous (e.g. carbon black, carbon nanotube, carbon fibre, graphene, graphite) materials.

Two electrodes of the electrode assembly may form a sensor. The first electrode and the ground electrode (e.g. first electrode part of the ground electrode) may form a first sensor or first electrode pair. The second electrode and the ground electrode (e.g. second electrode part of the ground electrode) may form a second sensor or second electrode pair. The third electrode and the ground electrode (e.g. third electrode part of the ground electrode) may form a third sensor or third electrode pair. The fourth electrode and the ground electrode (e.g. fourth electrode part of the ground electrode) may form a fourth sensor or fourth electrode pair. The fifth electrode and the ground electrode (e.g. fifth electrode part of the ground electrode) may form a fifth sensor or fifth electrode pair. The fourth electrode and the fifth electrode may form a sixth sensor or sixth electrode pair.

The first electrode may form an open loop. The second electrode may form an open loop and/or the third electrode may form an open loop. The fourth electrode may form an open loop. The fifth electrode may form an open loop. Open loop electrode(s) enables electrode arrangement in few or a single electrode layer.

The electrode assembly may comprise a support layer, also denoted a support film. One or more electrodes may be formed, e.g. printed, on the proximal side of the support layer. One or more electrodes may be formed, e.g. printed, on the distal side of the support layer. The electrode assembly may have a stomal opening with a center point.

The support layer may comprise polymeric (e.g. polyurethane, PTFE, PVDF) and/or ceramic (e.g. alumina, silica) materials. In one or more exemplary base plates, the support layer is made of thermoplastic polyurethane (TPU). The support layer material may be made of or comprise one or more of polyester, a thermoplastic elastomer (TPE), polyamide, polyimide, Ethylene-vinyl acetate (EVA), polyurea, and silicones.

Exemplary thermoplastic elastomers of the support layer are styrenic block copolymers (TPS, TPE-s), thermoplastic polyolefinelastomers (TPO, TPE-o), thermoplastic Vulcanizates (TPV, TPE-v), thermoplastic polyurethanes (TPU), thermoplastic copolyester (TPC, TPE-E), and thermoplastic polyamides (TPA, TPE-A).

The electrode assembly/base plate may comprise a masking element configured to insulate at least parts of the electrodes from the first adhesive layer of the base plate. The masking element may comprise one or more, such as a plurality of, sensor point openings. The sensor point openings may comprise primary sensor point openings and/or secondary sensor point openings. The sensor point openings may comprise tertiary sensor point opening(s). The sensor point openings may comprise quaternary sensor point opening(s) A sensor point opening of the masking element overlaps at least one electrode of the electrode assembly when seen in the axial direction, e.g. to form a sensor point. For example, a primary sensor point opening may overlap a part of the ground electrode and/or a part of the fourth electrode. A secondary sensor point opening may overlap a part of the fourth electrode and/or a part of the fifth electrode. A tertiary sensor point opening may overlap a part of the fifth electrode and/or a part of the ground electrode.

The masking element may comprise one or more, such as a plurality of, terminal openings. The masking element may comprise polymeric (e.g. polyurethane, PTFE,

PVDF) and/or ceramic (e.g. alumina, silica) materials. In one or more exemplary base plates, the masking element is made of or comprises thermoplastic polyurethane (TPU). In one or more exemplary base plates, the masking element is made of or comprises polyester. The masking element material may be made of or comprise one or more of polyester, a thermoplastic elastomer (TPE), polyimide, polyimide, Ethylene-vinyl acetate (EVA), polyurea, and silicones.

Exemplary thermoplastic elastomers of the masking element are styrenic block copolymers (TPS, TPE-s), thermoplastic polyolefinelastomers (TPO, TPE-o), thermoplastic Vulcanizates (TPV, TPE-v), thermoplastic polyurethanes (TPU), thermoplastic copolyester (TPC, TPE-E), and thermoplastic polyamides (TPA, TPE-A).

The base plate may comprise a first intermediate element. The first intermediate element may be arranged between the electrodes/electrode layer and the first adhesive layer and/or between the second layer and the first adhesive layer. The first intermediate layer may be made of an insulating material.

The base plate may comprise a release liner. The release liner is a protective layer that protects adhesive layer(s) during transport and storage and is peeled off by the user prior to applying the base plate on the skin. The release liner may have a stomal opening with a center point.

The base plate may comprise a top layer. The top layer is a protective layer protecting the adhesive layer(s) from external strains and stress when the user wears the ostomy appliance. The electrodes, e.g. some or all the electrodes, may be arranged between the first adhesive layer and the top layer. The top layer may have a stomal opening with a center point. The top layer may have a thickness in the range from 0.01 mm to 1.0 mm, e.g. in the range from 0.02 mm to 0.2 mm, such as 0.04 mm.

The base plate comprises a monitor interface. The monitor interface may be configured for electrically and/or mechanically connecting the ostomy appliance (base plate) to the monitor device. The monitor interface may be configured for wirelessly connecting the ostomy appliance (base plate) to the monitor device. Thus, the monitor interface of the base plate is configured to electrically and/or mechanically couple the ostomy appliance and the monitor device.

The monitor interface of the base plate may comprise, e.g. as part of a first connector of the monitor interface, a coupling part for forming a mechanical connection, such as a releasable coupling between the monitor device and the base plate. The coupling part may be configured to engage with a coupling part of the monitor device for releasably coupling the monitor device to the base plate.

The monitor interface of the base plate may comprise, e.g. as part of a first connector of the monitor interface, a plurality of terminals, such as two, three, four, five, six, seven or more terminals, for forming electrical connections with respective terminals of the monitor device. The monitor interface may comprise a ground terminal element forming a ground terminal. The monitor interface may comprise a first terminal element forming a first terminal, a second terminal element forming a second terminal and optionally a third terminal element forming a third terminal. The monitor interface may comprise a fourth terminal element forming a fourth terminal and/or a fifth terminal element forming a fifth terminal. The monitor interface optionally comprises a sixth terminal element forming a sixth terminal. The terminal elements of the monitor interface may contact respective electrodes of the base plate/electrode assembly. The first intermediate element may be arranged between the terminal elements and the first adhesive layer. The first intermediate element may cover or overlap terminal element(s) of the base plate when seen in the axial direction. Thus, the first adhesive layer may be protected or experience more evenly distributed mechanical stress from the terminal elements of the base plate, in turn reducing the risk of terminal elements penetrating or otherwise damaging the first adhesive layer. The first intermediate element may protect or mechanically and/or electrically shield the first adhesive layer from the terminal elements of the base plate.

The base plate may comprise a coupling ring or other coupling member for coupling an ostomy pouch to the base plate (two-part ostomy appliance). The center point may be defined as a center of the coupling ring.

The base plate has a stomal opening with a center point. The size and/or shape of the stomal opening is typically adjusted by the user or nurse before application of the ostomy appliance to accommodate the user's stoma. In one or more exemplary base plates, the user forms the stomal opening during preparation of the base plate for application.

The present disclosure provides a monitor device for an ostomy system, such as the ostomy system disclosed herein. The monitor device comprises a processor, memory, a first interface connected to the processor and the memory, the first interface configured for connecting to an ostomy appliance; and a second interface comprising a transceiver connected to the processor for transmitting monitor data according to a transmission scheme. The second interface is configured for connecting to one or more accessory devices. The processor may comprise a transmission controller configured to control the transmission scheme, wherein to control the transmission scheme comprises applying a primary transmission scheme or a secondary transmission scheme different from the primary transmission scheme.

The present disclosure provides a method of monitoring an ostomy appliance with a monitor device comprising a processor; memory; and a first interface connected to the processor and the memory and a second interface configured for connecting to one or more accessory devices, the first interface comprising a plurality of terminals including a ground terminal and a first terminal, and the second interface comprising a transceiver connected to the processor for transmitting monitor data. The method comprises obtaining monitor data based on ostomy data and/or parameter data of the ostomy appliance; and controlling transmission of the monitor data according to a transmission scheme, wherein controlling the transmission of the monitor data comprises applying a primary transmission scheme or a secondary transmission scheme different from the primary transmission scheme.

The monitor device comprises a processor and one or more interfaces, such as a first interface and/or a second interface. The monitor device may comprise a memory for storing ostomy data and/or parameter data.

In one or more exemplary monitor devices, the processor is configured to apply a processing scheme, the first interface is connected to the processor and the memory, and the first interface is configured for collecting ostomy data from the base plate coupled to the first interface. The ostomy data may comprise one or more, such as all, of first ostomy data from a first electrode pair of the base plate, second ostomy data from a second electrode pair of the base plate, and third ostomy data from a third electrode pair of the base plate. A second interface is connected to the processor. To apply a processing scheme may comprise one or more of obtain first parameter data based on the first ostomy data; obtain second parameter data based on the second ostomy data; and obtain third parameter data based on the third ostomy data. To apply a processing scheme may comprise determine an operating state of the base plate of the ostomy appliance based on one or more, such as all, of the first parameter data, the second parameter data and the third parameter data. The operating state may be indicative of a degree of radial erosion of the base plate, such as of the first adhesive layer, and/or an acute leakage risk for the ostomy appliance. The monitor device is configured to, in accordance with a determination that the operating state is a first operating state, transmit a first monitor signal comprising monitor data indicative of the first operating state of the base plate via the second interface; and/or in accordance with a determination that the operating state is a second operating state, transmit a second monitor signal comprising monitor data indicative of the second operating state of the base plate via the second interface.

In one or more exemplary monitor devices, the first operating state of the base plate corresponds to a situation wherein the first adhesive layer of the base plate has experienced a first degree of radial erosion, e.g. the first adhesive layer is eroded to a first radial distance of the first electrode pair but not to a second radial distance of the second electrode pair.

In one or more exemplary monitor devices, the second operating state of the base plate corresponds to a situation wherein the first adhesive layer of the base plate has experienced a second degree of radial erosion, e.g. the first adhesive layer is eroded to the second radial distance of the second electrode pair but not to a third radial distance of the third electrode pair.

To obtain first parameter data based on the first ostomy data may comprise determining one or more first parameters based on the first ostomy data. To obtain second parameter data based on the second ostomy data may comprise determining one or more second parameters based on the second ostomy data. To obtain third parameter data based on the third ostomy data may comprise determining one or more third parameters based on the third ostomy data. In one or more exemplary monitor devices, determination of an operating state may be based on one or more first parameters, such as first primary parameter and/or first secondary parameter of first parameter data. In one or more exemplary monitor devices, determination of an operating state may be based on one or more second parameters, such as second primary parameter and/or second secondary parameter of the second parameter data. In one or more exemplary monitor devices, determination of an operating state may be based on one or more third parameters, such as third primary parameter and/or third secondary parameter of the third parameter data. In one or more exemplary monitor devices, determination of an operating state may be based on one or more fourth parameters, such as fourth primary parameter and/or fourth secondary parameter of the fourth parameter data.

The first parameter data, the second parameter data, and the third parameter data may be indicative of resistance between the first electrode pair, the second electrode pair, and the third electrode pair, respectively. The first parameter data, the second parameter data, and the third parameter data may be indicative of voltage between the first electrode pair, the second electrode pair, and the third electrode pair, respectively (and thus indicative of resistance). The first parameter data, the second parameter data, and the third parameter data may be indicative of current between the first electrode pair, the second electrode pair, and the third electrode pair, respectively (and thus indicative of resistance).

The first parameter data, the second parameter data, and the third parameter data may be indicative of a rate of change in resistance between the first electrode pair, the second electrode pair, and the third electrode pair, respectively. In one or more exemplary monitor devices, the first parameter data, the second parameter data, and the third parameter data may be indicative of a rate of change in voltage between the first electrode pair, the second electrode pair, and the third electrode pair, respectively. In one or more exemplary monitor devices, the first parameter data, the second parameter data, and the third parameter data may be indicative of a rate of change in current between the first electrode pair, the second electrode pair, and the third electrode pair, respectively.

In one or more exemplary monitor devices, to determine an operating state of the base plate is based on a first criteria set based on the first parameter data and/or the second parameter data, wherein the operating state is determined to be the first operating state if the first criteria set is satisfied. The first criteria set may comprise one or more first criteria based on one or more of first parameter data, second parameter data and third parameter data. The first criteria set may comprise a first primary criterion based on the first parameter data. The first criteria set may comprise a first secondary criterion based on the second parameter data. The first criteria set may comprise a first tertiary criterion based on the third parameter data.

In one or more exemplary monitor devices, to determine an operating state of the base plate may be based on a first threshold set comprising one or a plurality of first threshold values. The first threshold set may comprise one or a plurality of threshold values, e.g. to be applied in the first criteria set. The first threshold set may comprise a first primary threshold value. The first threshold set may comprise a first secondary threshold value. The first threshold set may comprise a first tertiary threshold value.

The first criteria set may be given by or at least may comprise:

(P_1_1<TH_1_1),

(P_2_1>TH_1_2), and

(P_3_1>TH_1_3),

wherein P_1_1 is a first primary parameter based on the first parameter data, TH_1_1 is a first primary threshold value, P_2_1 is a second primary parameter based on the second parameter data, TH_1_2 is a first secondary threshold value, P_3_1 is a third primary parameter based on the third parameter data, and TH_1_3 is a first tertiary threshold value, and wherein the first operating state is indicative of low degree of radial erosion on the base plate. The first threshold values (TH_1_1, TH_1_2 and TH_1_3) may be the same or different, e.g. depending on the electrode configuration of the base plate. The first tertiary criterion (P_3_1<TH_1_3) may be omitted in the first criteria set. The first operating state, e.g. indicative of low degree of radial erosion on the base plate may be indicative of a radial progression of moisture to the first electrode pair (but not to the second electrode pair and not to the third electrode pair) which corresponds to e.g. an un-alarming and/or normal radial progression of moisture.

In one or more exemplary embodiments, when the first parameter data, the second parameter data and the third parameter data are each respectively indicative of resistance between the first electrode pair, the second electrode pair and the third electrode pair respectively, the first threshold values (TH_1_1, TH_1_2 and TH_1_3) may correspond to first resistance threshold values. In one or more exemplary embodiments, the first primary threshold value TH_1_1 may correspond to an upper resistance threshold value. An upper resistance threshold value may be set to a value which is less than 30 Mega-Ohms, such as 25 Mega-Ohms, such as 20.5 Mega-Ohms, such as 20.4 Mega-Ohms. In one or more exemplary embodiments, the first secondary threshold value TH_1_2 may correspond to the upper resistance threshold value. In one or more exemplary embodiments, the first tertiary threshold value TH_1_3 may correspond to the upper resistance threshold value.

The first primary parameter P_1_1 may be indicative of the resistance between the first electrode pair (first electrode and first electrode part of the ground electrode) of the base plate. The first parameter data may comprise a first secondary parameter which may be derived from the first primary parameter, and/or a first tertiary parameter, which may be derived from the first primary parameter. A first secondary parameter P_1_2 may comprise or be a gradient derived from the first primary parameter. In one or more embodiments, a first primary parameter P_1_1 may be indicative of a voltage between the first electrode pair (first electrode and first electrode part of the ground electrode) of the base plate.

In one or more exemplary embodiments, when the first parameter data, the second parameter data and the third parameter data are each respectively indicative of voltage between the first electrode pair, the second electrode pair and the third electrode pair respectively, the first threshold values (TH_1_1, TH_1_2 and TH_1_3) may correspond to first voltage threshold values. In one or more exemplary embodiments, the first primary threshold value TH_1_1 may correspond to an upper voltage threshold value. An upper voltage threshold value may be set to a value less than 5 Volts, such as 3 Volts, such as 2, 86 Volts. In one or more exemplary embodiments, the first secondary threshold value TH_1_2 may correspond to the upper voltage threshold value. In one or more exemplary embodiments, the first tertiary threshold value TH_1_3 may correspond to the upper voltage threshold value.

The first criteria set may comprise e.g.

(P_4_1>TH_1_4)

wherein P_4_1 is a fourth primary parameter based on the fourth parameter data and indicative of the resistance, voltage, or current between the fourth electrode pair and TH_1_4 is a first quaternary threshold value, and wherein the first operating state is indicative of absence of fluid on the proximal side of the first adhesive layer of the base plate of the ostomy appliance. In one or more exemplary embodiments, the first quaternary threshold value TH_1_4 may correspond to an upper resistance threshold value. An upper resistance threshold value may be set to a value which is less than 30 Mega-Ohms, such as 25 Mega-Ohms, such as 20.5 Mega-Ohms, such as 20.4 Mega-Ohms.

In one or more exemplary embodiments, the following additional criterion may be determined

(P_1_1<TH_low),

wherein P_1_1 is a first primary parameter based on the first parameter data, TH_low is a threshold value corresponding to a lower resistance threshold value. In one or more exemplary embodiments, a lower resistance threshold value may be set to a value less than 1 Mega-Ohms, such as 100 kilo-Ohms, such as 80 kilo-Ohms, such as 79 kilo-Ohms. This is indicative of a saturation of the first electrode pair by the moisture detected and there are no further changes expected by the first primary parameter. Moisture is likely to continue its progression.

In one or more exemplary embodiments, the following additional criterion may be determined

(P_2_1<TH_low),

wherein P_2_1 is a second primary parameter based on the second parameter data, TH_low is a threshold value corresponding to a lower resistance threshold value. In one or more exemplary embodiments, a lower resistance threshold value may be set to a value less than 1 Mega-Ohms, such as 100 kilo-Ohms, such as 80 kilo-Ohms, such as 79 kilo-Ohms. This is indicative of a saturation of the second electrode pair by the moisture detected and there are no further changes expected by the second primary parameter. Moisture is likely to continue its progression.

In one or more exemplary embodiments, the following additional criterion may be determined:

(P_3_1>TH_low),

P_3_1 is a third primary parameter based on the third parameter data, and TH_low is a threshold value corresponding to a lower resistance threshold value. In one or more exemplary embodiments, a lower resistance threshold value may be set to a value less than 1 Mega-Ohms, such as 100 kilo-Ohms, such as 80 kilo-Ohms, such as 79 kilo-Ohms. This is indicative of a saturation of the third electrode pair by the moisture detected and there are no further changes expected by the second primary parameter. Moisture is likely to continue its progression.

In one or more exemplary embodiments, one or more criteria of a criteria set, e.g. one or more first criteria of the first criteria set and/or one or more second criteria of the second criteria set, may be based on timing information or one or more delay parameters based on the parameter data. In one or more exemplary embodiments, one or more delay parameters or time differences related to different parameter data, e.g. related to the first parameter data and the second parameter data, are determined.

In one or more exemplary embodiments, one or more first criteria of the first criteria set may be based on timing information (e.g. one or more delay parameters of the parameter data and/or one or more times where a parameter crosses a threshold).

In one or more exemplary embodiments, the timing information may comprise a time difference D_1_2_1 between a time T1 where P_1_1 crosses a threshold, such as TH_1_1, and a time T2 where P_2_1 crosses a threshold, such as TH_1_2 . Thus, delay parameter or time difference D_1_2_1 may be given as D_1_2_1=T2−T1.

In one or more exemplary embodiments, the timing information, e.g. used in the first criteria set, may comprise a time difference D_2_3_1 between a time T2 where P_2_1 crosses a threshold, such as TH_1_2 , and a time T3 where P_3_1 crosses a threshold, such as TH_1_3 . Thus, delay parameter or time difference D_2_3_1 may be given as D_2_3_1=T3−T2.

In one or more exemplary embodiments, one or more criteria sets, such as the third criteria set and/or the second criteria set, may comprise any of:

D_1_2_1>Z

D_2_3_1>Z

Wherein Z is a time difference constant characterizing the progression of moisture (e.g. 3 h, e.g. 2 h). Different time difference constants may be employed in different criteria sets/for different time delays.

In one or more exemplary embodiments, one or more criteria sets, such as the second criteria set and/or the third criteria set may comprise any of:

D_1_2_1>Z

Wherein Z is a time difference constant characterizing the progression of moisture (e.g. 3 h, e.g. 2 h).

The second primary parameter may be indicative of the resistance between the second electrode pair (second electrode and second electrode part of the ground electrode) of the base plate. The second parameter data may comprise a second secondary parameter, and/or a second tertiary parameter, which may be derived from the second primary parameter. A second secondary parameter may be indicative of a voltage between the second electrode pair (second electrode and second electrode part of the ground electrode) of the base plate.

The third primary parameter may be indicative of resistance between the third electrode pair (third electrode and third electrode part of the ground electrode) of the base plate. The third parameter data may comprise a third secondary parameter, and/or a third tertiary parameter, which may be derived from the third primary parameter. A third secondary parameter may be indicative of a voltage between the second electrode pair (second electrode and second electrode part of the ground electrode) of the base plate.

In one or more exemplary monitor devices, to determine an operating state of the base plate is based on a second criteria set based on the second parameter data and/or the third parameter data, wherein the operating state is determined to be the second operating state if the second criteria set is satisfied. The second criteria set may be based on the first parameter data.

The second criteria set may comprise one or more second criteria based on one or more of first parameter data, second parameter data and third parameter data. The second criteria set may comprise a second primary criterion based on the first parameter data. The second criteria set may comprise a second secondary criterion based on the second parameter data. The second criteria set may comprise a second tertiary criterion based on the third parameter data.

In one or more exemplary monitor devices, to determine an operating state of the base plate is based on a second threshold set comprising one or a plurality of second threshold values. The second threshold set may comprise one or a plurality of threshold values, e.g. to be applied in the second criteria set. The second threshold set may comprise a second primary threshold value. The second threshold set may comprise a second secondary threshold value. The second threshold set may comprise a second tertiary threshold value.

The second criteria set may be given by or at least may comprise:

(P_1_1 <TH_2_1),

(P_2_1 <TH_2_2), and

(P_3_1 >TH_2_3)

wherein P_1_1 is a first primary parameter based on the first parameter data and indicative of the resistance between the first electrode pair, TH_2_1 is a second primary threshold value, P_2_1 is a second primary parameter based on the second parameter data and indicative of the resistance between the second electrode pair, TH_2_2 is a second secondary threshold value, P_3_1 is a third primary parameter based on the third parameter data and indicative of the resistance between the third electrode pair, TH_2_3 is a second tertiary threshold value, and wherein the second operating state is indicative of medium degree of radial erosion on the base plate. The second threshold values (TH_2_1, TH_2_2 and TH_2_3) may be the same or different, e.g. depending on the electrode configuration of the base plate. The second primary criterion (P_1_1 <TH_2_1) and/or the second tertiary criterion (P_3_1>TH_2_3) may be omitted in the second criteria set. The second operating state indicative of medium degree of radial erosion on the base plate may be indicative of a radial progression of moisture to the first electrode pair and the second electrode pair (and not the third electrode pair). The second operating state indicative of medium degree of radial erosion on the base plate may be indicative of a radial progression of moisture to the first electrode pair and to the second electrode pair.

In one or more exemplary embodiments, when the first parameter data, the second parameter data and the third parameter data are each respectively indicative of resistance between the first electrode pair, the second electrode pair and the third electrode pair respectively, the second threshold values (TH_2_1, TH_2_2 and TH_2_3) may correspond to second resistance threshold values. In one or more exemplary embodiments, the second primary threshold value TH_2_1 may correspond to an upper resistance threshold value. An upper resistance threshold value may be set to a value which is less than 30 Mega-Ohms, such as 25 Mega-Ohms, such as 20.5 Mega-Ohms, such as 20.4 Mega-Ohms. In one or more exemplary embodiments, the second secondary threshold value TH_2_2 may correspond to the upper resistance threshold. In one or more exemplary embodiments, the second tertiary threshold value TH_2_3 may correspond to the upper resistance threshold value. In one or more exemplary embodiments, the second primary threshold value TH_2_1 may correspond to a medium resistance threshold value. A medium resistance threshold value may be set to a value less than 10 Mega-Ohms, such as 5 Mega-Ohms, such as 3 Mega-Ohms, such as 2 Mega-Ohms, such as 1 Mega-Ohms.

In one or more exemplary embodiments, when the first parameter data, the second parameter data and the third parameter data are each respectively indicative of voltage between the first electrode pair, the second electrode pair and the third electrode pair respectively, the second threshold values (TH_2_1, TH_2_2 and TH_2_3) may correspond to second voltage threshold values. In one or more exemplary embodiments, the second primary threshold value TH_2_1 may correspond to an upper voltage threshold value. An upper voltage threshold value may be set to a value less than 5 Volts, such as 3 Volts, such as 2.86 Volts. In one or more exemplary embodiments, the second secondary threshold value TH_2_2 may correspond to the upper voltage threshold value. In one or more exemplary embodiments, the second tertiary threshold value TH_2_3 may correspond to the upper voltage threshold value. In one or more exemplary embodiments, the second primary threshold value TH_2_1 may correspond to a medium voltage threshold value. A medium resistance threshold value may be set to a value less than 10 Mega-Ohms, such as 5 Mega-Ohms, such as 3 Mega-Ohms, such as 2 Mega-Ohms, such as 1 Mega-Ohms.

In one or more exemplary embodiments, the second criteria set may comprise any of:

D_1_2_1>Z

Wherein Z is a time difference constant characterizing the progression of moisture (e.g. 3 h, e.g. 2 h).

In one or more exemplary monitor devices, to determine an operating state of the base plate is based on a default criteria set based on the first parameter data, wherein the operating state is determined to be the default operating state if the default criteria set is satisfied, and in accordance with a determination that the operating state is the default operating state, transmit a default monitor signal comprising monitor data indicative of the default operating state of the ostomy appliance.

The default criteria set may be given by or at least may comprise

(P_1_1>TH_D_1),

(P_2_1>TH_D_2), and

(P_3_1>TH_D_3)

wherein P_1_1 is a first primary parameter based on the first parameter data and indicative of the resistance between the first electrode pair, TH_D_1 is a default primary threshold value, P_2_1 is a second primary parameter based on the second parameter data and indicative of the resistance between the second electrode pair, TH_D_2 is a default secondary threshold value, P_3_1 is a third primary parameter based on the third parameter data and indicative of the resistance between the third electrode pair, TH_D_3 is a default tertiary threshold value, and wherein the default operating state is indicative of very low or no degree of radial erosion on the base plate. The default threshold values (TH_D_1, TH_D_2 and TH_D_3) may be the same or different, e.g. depending on the electrode configuration of the base plate. In one or more exemplary embodiments, when the first parameter data, the second parameter data and the third parameter data are each respectively indicative of resistance between the first electrode pair, the second electrode pair and the third electrode pair respectively, the default threshold values (TH_D_1, TH_D_2 and TH_D_3) may correspond to default resistance threshold values. In one or more exemplary embodiments, the second primary threshold value TH_D_1 may correspond to an upper resistance threshold value. An upper resistance threshold value may be set to a value which is less than 30 Mega-Ohms, such as 25 Mega-Ohms, such as 20.5 Mega-Ohms, such as 20.4 Mega-Ohms. In one or more exemplary embodiments, the default secondary threshold value TH_D_2 may correspond to the upper resistance threshold. In one or more exemplary embodiments, the default tertiary threshold value TH_D_3 may correspond to the upper resistance threshold value.

In one or more exemplary embodiments, when the first parameter data, the second parameter data and the third parameter data are each respectively indicative of voltage between the first electrode pair, the second electrode pair and the third electrode pair respectively, the default threshold values (TH_D_1, TH_D_2 and TH_D_3) may correspond to default voltage threshold values. In one or more exemplary embodiments, the default primary threshold value TH_D_1 may correspond to an upper voltage threshold value. An upper voltage threshold value may be set to a value less than 5 Volts, such as 3 Volts, such as 2.86 Volts. In one or more exemplary embodiments, the default secondary threshold value TH_D_2 may correspond to the upper voltage threshold value. In one or more exemplary embodiments, the default tertiary threshold value TH_D_3 may correspond to the upper voltage threshold value.

In one or more exemplary monitor devices, to determine an operating state of the base plate is based on a third criteria set based on the third parameter data, wherein the operating state is determined to be the third operating state if the third criteria set is satisfied, and in accordance with a determination that the operating state is the third operating state, transmit a third monitor signal comprising monitor data indicative of the third operating state of the ostomy appliance.

In one or more exemplary monitor devices, the third operating state of the base plate corresponds to a situation wherein the first adhesive layer of the base plate has experienced a third degree of radial erosion, e.g. the first adhesive layer is eroded to the third radial distance of the third electrode pair.

The third criteria set may be given by or at least may comprise:

(P_1_1<TH_3_1),

(P_2_1<TH_3_2), and

(P_3_1<TH_3_3)

wherein P_1_1 is a first primary parameter based on the first parameter data and indicative of the resistance between the first electrode pair, TH_3_1 is a third primary threshold value, P_2_1 is a second primary parameter based on the second parameter data and indicative of the resistance between the second electrode pair, TH_3_2 is a third secondary threshold value, P_3_1 is a third primary parameter based on the third parameter data and indicative of the resistance between the third electrode pair, TH_3_3 is a third tertiary threshold value, and wherein the third operating state is indicative of high degree of radial erosion on the base plate. The third threshold values (TH_3_1, TH_3_2 and TH_3_3) may be the same or different, e.g. depending on the electrode configuration of the base plate. The third primary criterion (P_1_1<TH_3_1) and/or the third secondary criterion (P_2_1<TH_3_2) may be omitted in the third criteria set. The third operating state indicative of high degree of radial erosion on the base plate may be indicative of high likelihood of leakage, e.g. on the proximal side of the base plate, e.g. within a time period e.g. within the next 20 minutes. The third operating state may indicate a radial progression of moisture to the first electrode pair, the second electrode pair, and the third electrode pair.

In one or more exemplary embodiments, when the first parameter data, the second parameter data and the third parameter data are each respectively indicative of resistance between the first electrode pair, the second electrode pair and the third electrode pair respectively, the third threshold values (TH_3_1, TH_3_2 and TH_3_3) may correspond to third resistance threshold values. In one or more exemplary embodiments, the third primary threshold value TH_3_1 may correspond to an upper resistance threshold value. In one or more exemplary embodiments, the third secondary threshold value TH_3_2 may correspond to an upper resistance threshold value. In one or more exemplary embodiments, the third tertiary threshold value TH_3_3 may correspond to an upper resistance threshold value. An upper resistance threshold value may be set to a value which is less than 30 Mega-Ohms, such as 25 Mega-Ohms, such as 20.5 Mega-Ohms, such as 20.4 Mega-Ohms.

In one or more exemplary embodiments, the third primary threshold value TH_3_1 may correspond to a lower resistance threshold value. In one or more exemplary embodiments, a lower resistance threshold value may be set to a value less than 1 Mega-Ohms, such as 100 kilo-Ohms, such as 80 kilo-Ohms, such as 79 kilo-Ohms. In one or more exemplary embodiments, the third secondary threshold value TH_3_2 may correspond to a medium resistance threshold. A medium resistance threshold value may be set to a value less than 10 Mega-Ohms, such as 5 Mega-Ohms, such as 3 Mega-Ohms, such as 2 Mega-Ohms, such as 1 Mega-Ohms. In one or more exemplary embodiments, the third tertiary threshold value TH_3_3 may correspond to the upper resistance threshold. An upper resistance threshold value may be set to a value which is less than 30 Mega-Ohms, such as 25 Mega-Ohms, such as 20.5 Mega-Ohms, such as 20.4 Mega-Ohms.

In one or more exemplary embodiments, when the first parameter data, the second parameter data and the third parameter data are each respectively indicative of voltage between the first electrode pair, the second electrode pair and the third electrode pair respectively, the third threshold values (TH_3_1, TH_3_2 and TH_3_3) may correspond to third voltage threshold values. In one or more exemplary embodiments, the third primary threshold value TH_3_1 may correspond to an upper voltage threshold value. In one or more exemplary embodiments, the third secondary threshold value TH_3_2 may correspond to an upper voltage threshold value. In one or more exemplary embodiments, the second tertiary threshold value TH_2_3 may correspond to the upper voltage threshold value.

In one or more exemplary embodiments, the third primary threshold value TH_3_1 may correspond to a lower voltage threshold value. In one or more exemplary embodiments, a lower voltage threshold value may be set to a value which is less than 1 Volt, such as 0.5 Volt, such as 0.25 Volts, such as 0.22 Volts. In one or more exemplary embodiments, the third secondary threshold value TH_3_2 may correspond to a medium voltage threshold value. A medium voltage threshold value may be set to a value less than 2 Volts, such as 1.5 Volts. In one or more exemplary embodiments, the second tertiary threshold value TH_2_3 may correspond to the upper voltage threshold value.

In one or more exemplary embodiments, the third criteria set may comprise any of:

D_1_2_1<Z

D_2_3_1<Z

Wherein Z is a time difference constant characterizing the progression of moisture (e.g. 3 h, e.g. 2 h), a time difference D_1_2_1 between a time T1 where P_1_1 crosses TH_1_1 and a time T2 where P_2_1 crosses TH_1_2 , and a time difference D_2_3_1 between a time T2 where P_2_1 crosses TH_1_2 and a time T3 where P_3_1 crosses TH__3.

In one or more exemplary monitor devices, the ostomy data comprises fourth ostomy data from a fourth electrode pair of the base plate. To apply a processing scheme may comprise to obtain fourth parameter data based on the fourth ostomy data, and determine an operating state of the base plate of the ostomy appliance based on the fourth parameter data. The monitor device may be configured to, in accordance with a determination that the operating state is a fourth operating state, transmit a fourth monitor signal comprising monitor data indicative of the fourth operating state of the ostomy appliance.

In one or more exemplary monitor devices, the fourth operating state of the base plate corresponds to a situation, wherein the fourth electrode pair detects fluid, such as output, between the proximal surface of first adhesive layer and the skin of the user at a fourth radial distance, and thus there is a high risk of leakage from the ostomy appliance in the fourth operating state.

The fourth criteria set may be given by or at least may comprise:

(P_4_1<TH_4_4)

wherein P_4_1 is a fourth primary parameter based on the fourth parameter data and indicative of the resistance between the fourth electrode pair and TH_4_4 is a fourth quaternary threshold value, and wherein the fourth operating state is indicative of high risk of leakage from the ostomy appliance. In one or more exemplary embodiments, the fourth quaternary threshold value TH_4_4 may correspond to an upper resistance threshold value.

In one or more exemplary monitor devices, a fifth operating state of the base plate corresponds to a situation, wherein the fourth electrode pair detects fluid, such as sweat, between the proximal surface of first adhesive layer and the skin of the user at a fourth radial distance, and thus there is a no leakage from the ostomy appliance in the fifth operating state.

The fifth operating state may be determined in accordance with a determination that one or more fifth criterion of a fifth criteria set are satisfied.

The fifth criteria set may be given by or at least may comprise:

(P_4_1<TH_5_1)

(P_4_2<TH_5_2)

(P_4_3<TH_5_3)

(VP_4_1<V)

(VP_4_2<V) and

(VP_4_3<V)

Wherein P_4_1 is a fourth primary parameter based on the fourth parameter data and indicative of the resistance between the fourth electrode pair, P_4_2 is a fourth secondary parameter indicative of the resistance between the fourth electrode and the fifth electrode, P_4_3 is a fourth tertiary parameter based on the fourth parameter data and indicative of the resistance between the fifth electrode pair and TH_5_1 is a fifth primary threshold value, TH_5_2 is a fifth secondary threshold value TH_5_3 is a fifth tertiary threshold value and ∇P_4_1 is gradient of P_4_1, ∇P_4_2 is gradient of P_4_2, ∇P_4_3 is gradient of P_4_3, and V is a gradient limit (e.g. 80%). In one or more exemplary embodiments, the fifth primary threshold value TH_5_1 may correspond to an upper resistance threshold value. In one or more exemplary embodiments, TH_5_2 may correspond to an upper resistance threshold value. In one or more exemplary embodiments, TH_5_3 may correspond to an upper resistance threshold value. An upper resistance threshold value may be set to a value which is less than 30 Mega-Ohms, such as 25 Mega-Ohms, such as 20.5 Mega-Ohms, such as 20.4 Mega-Ohms. The fifth operating state may refer to presence of sweat detected by the fourth parameter data indicating moisture detected omnidirectionally from the stomal opening and uniformly.

In one or more exemplary monitor devices, the sixth operating state of the base plate corresponds to a situation, wherein the fourth electrode pair detects fluid, such as output, between the proximal surface of first adhesive layer and the skin of the user at a fourth radial distance, and thus there is a sudden leakage from the ostomy appliance in the sixth operating state.

A sixth operating state may be determined in accordance with a determination that one or more sixth criteria of a sixth criteria set are satisfied.

The sixth criteria set may comprise a sixth primary criterion, wherein the sixth primary criterion may comprise:

(P_4_1<TH_6_1) and

(ΔP_4_1>V)

The sixth criteria set may comprise a sixth secondary criterion, wherein the sixth secondary criterion may comprise:

(P_4_2<TH_6_2) and

(ΔP_4_2>V)

The sixth criteria set may comprise a sixth tertiary criterion, wherein the sixth tertiary criterion may comprise:

(P_4_3<TH_6_3) and

(ΔP_4_3>V)

Wherein P_4_1 is a fourth primary parameter based on the fourth parameter data and indicative of the resistance between the fourth electrode pair, P_4_2 is a fourth secondary parameter indicative of the resistance between the fourth electrode and the fifth electrode, P_4_3 is a fourth tertiary parameter indicative of the resistance between the fifth electrode pair (fifth electrode and ground electrode) and TH_6_1 is a sixth primary threshold value, TH_6_2 is a sixth secondary threshold value TH_6_3 is a sixth tertiary threshold value, and ∇P_4_1 is gradient of P_4_1, ∇P_4_2 is gradient of P_4_2, ∇P_4_3 is gradient of P_4_3, and V is a gradient limit (e.g. 80%). In one or more exemplary embodiments, the sixth primary threshold value TH_6_1 may correspond to an upper resistance threshold value. In one or more exemplary embodiments, TH_6_2 may correspond to an upper resistance threshold value. In one or more exemplary embodiments, TH_6_3 may correspond to an upper resistance threshold value. An upper resistance threshold value may be set to a value which is less than 30 Mega-Ohms, such as 25 Mega-Ohms, such as 20.5 Mega-Ohms, such as 20.4 Mega-Ohms. The sixth operating state may refer to presence of output detected by the fourth parameter data indicating a sudden leak, e.g. a developing leak. In one or more exemplary embodiments, when the time T is below X minutes from the placement of the base plate, where X is between 5 to 60 minutes, and when any of P_1_1, P_2_1 , P_3_1 in average over T are below a default threshold value corresponding to an upper resistance threshold value, this indicates that any of the first electrode pair, the second electrode pair, and the third electrode pair is cut (e.g. cut by the user when preparing the base plate for placement around the stoma). In one or more exemplary embodiments, when the time T is below X minutes from the placement of the base plate, where X is between 5 to 60 minutes, and when any of P_4_1, P_4_2, P_4_3 in average over T are below a default threshold value corresponding to an upper resistance threshold value, this indicates an instant leakage, e.g. presence of output on the proximal side.

In one or more exemplary embodiments, any of the first criteria set, the second criteria set, the third criteria set, the fourth criteria set, the default criteria set, the fifth criteria set, the sixth criteria set may be used to define one or more further criteria sets, and thereby to determine one or more operating states.

In one or more exemplary embodiments, different criteria sets may be used to determine the same operating state.

The monitor device comprises a monitor device housing optionally made of a plastic material. The monitor device housing may be an elongate housing having a first end and a second end. The monitor device housing may have a length or maximum extension along a longitudinal axis in the range from 1 cm to 15 cm. The monitor device housing may have a width or maximum extension perpendicular to the longitudinal axis in the range from 0.5 cm to 3 cm. The monitor device housing may be curve-shaped.

The monitor device comprises a first interface connected to the processor and the memory. The first interface is configured for connecting to the ostomy appliance. The first interface may be configured as an appliance interface for electrically and/or mechanically connecting the monitor device to the ostomy appliance. Thus, the appliance interface is configured to electrically and/or mechanically couple the monitor device and the ostomy appliance. The first interface may be configured as an accessory device interface for electrically and/or mechanically connecting the monitor device to an accessory device, such as a docking station. The first interface may be configured for coupling to a docking station of the ostomy system, e.g. for charging the monitor device and/or for data transfer between the monitor device and the docking station.

The first interface of the monitor device may comprise a plurality of terminals, such as two, three, four, five, six, seven or more terminals, for forming electrical connections with respective terminals and/or electrodes of the ostomy appliance. One or more terminals of the first interface may be configured for forming electrical connections with an accessory device, e.g. with respective terminals of a docking station. The first interface may comprise a ground terminal. The first interface may comprise a first terminal, a second terminal and optionally a third terminal. The first interface may comprise a fourth terminal and/or a fifth terminal. The first interface optionally comprises a sixth terminal. In one or more exemplary monitor devices, the first interface has M terminals, wherein M is an integer in the range from 4 to 8.

The first interface of the monitor device may comprise a coupling part for forming a mechanical connection, such as a releasable coupling between the monitor device and the base plate. The coupling part and the terminals of the first interface form (at least part of) a first connector of the monitor device.

The monitor device may comprise a sensor unit with one or more sensor. The sensor unit is connected to the processor for feeding sensor data to the processor. The sensor unit may comprise an accelerometer for sensing acceleration and provision of acceleration data to the processor. The sensor unit may comprise a temperature sensor for provision of temperature data to the processor.

The monitor device comprises a second interface connected to the processor. The second interface may comprise a transceiver for transmitting monitor data according to a transmission scheme. The second interface may comprise a transceiver connected to the processor for transmitting monitor data according to a transmission scheme. The second interface is configured for connecting to one or more accessory devices. In other words, the second interface may be configured as an accessory interface for connecting, e.g. wirelessly connecting, the monitor device to one or more accessory devices. The second interface may comprise an antenna and the transceiver comprising a wireless transceiver, e.g. configured for wireless communication at frequencies in the range from 2.4 to 2.5 GHz. The wireless transceiver may be a Bluetooth transceiver, i.e. the wireless transceiver may be configured for wireless communication according to Bluetooth protocol, e.g. Bluetooth Low Energy, Bluetooth 4.0, Bluetooth 5. The second interface optionally comprises a loudspeaker and/or a haptic feedback element for provision of an audio signal and/or haptic feedback to the user, respectively.

The processor comprises a transmission controller configured to control the transmission scheme. The transmission controller may be configured to control the transmission scheme by applying a primary transmission scheme or a secondary transmission scheme different from the primary transmission scheme. By transmitting monitor data using different transmission schemes (e.g. with different frequencies), characteristics of the ostomy appliance that are more likely to change quickly can be more frequently transmitted while characteristics that are less likely to change quickly can be less frequently transmitted. As such, the longevity of a power unit supplying power to the monitor device may be increased and/or storage of the memory on which the monitor data corresponding to the characteristics may be better utilized.

In one or more exemplary monitor devices, the transmission controller is configured to determine the transmission scheme based on one or more control parameters. For example, to determine the transmission scheme may comprise to determine one or more control parameters. For example, a control parameter may refer to a parameter or indicator that is configured to control the selection of the transmission scheme to be applied by the transmission controller.

In one or more exemplary monitor devices, the first transmission scheme comprises a first transmission parameter. In one or more exemplary monitor devices, the second transmission scheme comprises a second transmission parameter. In one or more exemplary monitor devices, the first transmission parameter and the second transmission parameter are different. A transmission parameter may comprise a transmission frequency, a transmission periodicity, a transmission signal phase, a transmission power, a transmission radio frequency, a transmission protocol (e.g. Bluetooth, Bluetooth Low Energy, ZigBee, WLAN, cellular protocol, connection to the docking station) and/or any combination thereof.

In one or more exemplary monitor devices, the one or more control parameters comprise a control parameter indicative of an operating state of the ostomy appliance. An operating state of the ostomy appliance is indicative of the dynamic internal state of the ostomy appliance, which may be affected by e.g. adhesive performance of the ostomy appliance, a condition inside the adhesive layer (e.g. which may affect by several factors such as humidity, temperature), misplacement of the ostomy appliance on the stoma, and/or malfunction of the ostomy appliance. One or more factors alone or in combination impact the operating state of the ostomy appliance. The operating state may be indicative of wear property, e.g. wear time and/or wear comfort. An operating state in the present disclosure is for example configured to indicate whether the ostomy appliance needs to be changed. For example, the operating state may be indicative of the severity and/or imminence of the required change (e.g. low, medium, acute). The operating state may comprise N operating states, where N is an integer. The operating state may comprise a first operating state, a second operating state, a third operating state (e.g. good, check, change in X time, change NOW). In one or more exemplary monitor devices, characteristics of the ostomy appliance may be monitored (e.g., the operating state of the ostomy appliance) and, based on these characteristics, it may be beneficial to select a specific transmission scheme based on, potentially different operating states. For example, when the adhesion between the first adhesive layer and the skin surface of the user degrades below a threshold level, as indicated by the operating state, it may not be necessary to notify a user immediately. However, when a leak is detected, as indicated by the operating state, the user may want to be notified immediately so the user can take appropriate action.

In one or more exemplary monitor devices, the one or more control parameters comprises a control parameter indicative of a power capacity of a power unit of the monitor device. The monitor device comprises a power unit for powering the monitor device. The power unit may comprise a battery. The power unit may comprise charging circuitry connected to the battery and terminals of the first interface for charging the battery via the first interface, e.g. the first connector. The first interface may comprise separate charging terminal(s) for charging the battery. The power unit has a power capacity, such as a power capacity at the time of the control of the transmission scheme, such as a current power capacity of the power unit of the monitor device.

In one or more exemplary monitor devices, the one or more control parameters comprises a control parameter indicative of an appliance model of the ostomy appliance. An appliance model of the ostomy appliance may have one or more features that are to be considered when determining the transmission scheme to be applied. A control parameter indicative of an appliance model of the ostomy appliance may comprise an appliance model type, an appliance model identifier, such as a serial number, such as a product line name, such as a hardware identifier. A control parameter indicative of an appliance model of the ostomy appliance may comprise an appliance model identifier that uniquely identifies an ostomy appliance amongst a plurality of ostomy appliances, wherein each appliance model has one or more features (e.g. base plate type, pouch type).

In one or more exemplary monitor devices, the one or more control parameters comprises a control parameter indicative of a data collection scheme of the monitor device. A data collection scheme refers to a scheme that defines how ostomy data is collected from the ostomy appliance by the monitor device (e.g. amount of data to be collected, data collection frequency, data type (e.g. which electrodes, which metric)). Due to the different terminals indicating different characteristics of the ostomy appliance, it may be beneficial to collect data of the different characteristics according to different data collection schemes and to adjust the transmission scheme to the data collection scheme being applied. A control parameter indicative of a data collection scheme may comprise a data collection scheme identifier that uniquely identifies a data collection scheme amongst a plurality of data collection schemes, wherein each data collection scheme has one or more data collection parameters (e.g. amount of data to be collected, data collection frequency, data type). By collecting data with different data collection schemes having respectively different collection frequencies and adapting the transmission scheme to the different data collection schemes, characteristics of the ostomy appliance that are more likely to change quickly can be more frequently monitored and transmitted while characteristics that are less likely to change quickly can be less frequently monitored and transmitted. As such, the longevity of a power unit supplying power to the monitor device may be increased and/or storage of the memory on which the data corresponding to the characteristics may be better utilized.

In one or more exemplary monitor devices, the one or more control parameters comprises a control parameter indicative of a data processing scheme of the monitor device. A data processing scheme refers to a scheme that defines how ostomy data is processed by the processor to generate parameter data (e.g. what parameter data is to be generated, what ostomy data is to be used to generate the parameter data, the function to be applied on the ostomy data). A control parameter indicative of a data processing scheme may comprise a data processing scheme identifier that identifies a data processing scheme amongst a plurality of data processing schemes, wherein each data processing scheme has one or more data processing parameters (e.g. what parameter data is to be generated, what ostomy data is to be used to generate the parameter data, the function to be applied on the ostomy data).

In one or more exemplary monitor devices, the one or more control parameters comprises a control parameter indicative of size of ostomy data and/or of the size of monitor data in the memory. In one or more exemplary monitor devices, the one or more control parameters comprises a control parameter indicative of size of parameter data. A size may refer to a quantity of data, expressed in bits, bytes, and/or any related metric. The transmission controller may be configured to adjust a transmission parameter based on the size of any one or more of ostomy data, parameter data, monitor data. It may be envisaged that when the size of any one or more of ostomy data, parameter data, monitor data is negligible (e.g. below a data size threshold), the transmission controller is configured to adjust the transmission parameter accordingly (e. g. reduce transmission frequency, or increase transmission periodicity). Additionally, or alternatively, it may be envisaged that when the size of any one or more of ostomy data, parameter data, monitor data is above a data size threshold, the transmission controller is configured to transmit the monitor data immediately.

For example, applying a first transmission scheme comprises transmitting a first monitor data set with a first data size. For example, applying a second transmission scheme comprises transmitting a second monitor data set with a second data size different from the first data size, e.g. to reduce data size (e.g. when the power unit indicate a low power, e.g. below a power threshold). The second transmission scheme may be a data dump transmission scheme, where the memory is emptied from monitor data in its entirety.

In one or more exemplary monitor devices, the one or more control parameters comprises a control parameter indicative of a wear time of the ostomy appliance. Wear time is indicative of the time that the ostomy appliance has been worn by the user, or the time that is left for the worn ostomy appliance before the ostomy appliance needs to be changed. Wear time may be expressed in time units. For example, the transmission controller may control the transmission frequency based on the wear time, such as transmitting monitor data every time the wear time changes by a certain percentage (e.g. 5%, 10%, 15%, 25%). For example, when the user has been wearing the ostomy appliance for a period of time that exceeds a threshold, monitor data may be transmitted at a higher rate (e.g. at a higher throughput, and/or with a smaller periodicity) than if the wear time is less than the threshold. An advantage of transmitting monitor data at a higher rate when the wear time is greater than a threshold is because the adhesion between the first adhesive layer and the skin surface of the user will likely degrade over time. When the adhesion between the first adhesive layer and the skin surface of the user degrades, the likelihood of a leak increases. As such, the transmission controller may be configured to control the transmission scheme by applying a second transmission scheme with a higher frequency when the wear time of the ostomy appliance has surpassed a threshold. In one or more exemplary monitor devices, the transmission controller may be configured to determine whether the wear time has surpassed the threshold. Additionally, or alternatively, the threshold may be input into the monitor device and/or based on a previous wear time of the ostomy appliance by the user.

In one or more exemplary monitor devices, the one or more control parameters comprises a control parameter indicative of preferences of a user of the ostomy appliance. Preferences of a user may comprise a frequency of checking the operating state of the ostomy appliance by the user, a frequency of user notification related to the ostomy appliance, an appliance model, use of additional seals. A control parameter indicative of preferences of a user may comprise an indicator for frequency of checking the operating state of the ostomy appliance, an indicator for frequency of user notification, an appliance model identifier.

In one or more exemplary monitor devices, the one or more control parameters comprises a control parameter indicative of a location of a user of the ostomy appliance. Location refers herein to the geographic localization of the user, such as indoor localization, and/or outdoor localization. A control parameter indicative of a location of a user of the ostomy appliance may comprise location information, such as indoor location information, such as outdoor location information. For example, the transmission controller may control the transmission scheme based on the location information. For example, the transmission controller may control the transmission scheme by adjusting the transmission parameter (e.g. the amount of data to transmit, the transmission power, the transmission protocol) based on the location information (e.g. when indoor location is determined). Furthermore, users of ostomy appliances may differ in their ostomy habits based on the location of the users in the world. For example, users in a first country may change their ostomy appliances more frequently than users in a second country due to, perhaps, better healthcare subsidies. The transmission controller may be configured to determine the transmission scheme which is adjusted based on the location and related information as to frequency with which the ostomy appliance is changed.

In one or more exemplary monitor devices, the one or more control parameters comprises a control parameter indicative of an activity level of a user. An activity level of a user may be indicative of the user being stationary, sedentary, in motion, in exercising motion, in physical effort. A control parameter indicative of an activity level of a user may comprise an activity level identifier and/or an activity level percentage. For example, the transmission controller may control the transmission scheme by adjusting the transmission parameter (e.g. the amount of data to transmit, the transmission frequency) based on the activity level identifier and/or the activity level percentage (e.g. exercising). For example, if the user's activity level is high (e.g., when the use is running), monitor data may be transmitted at a higher rate than if the user is being less active. The reason being is because the adhesion between the first adhesive layer and the skin surface of the user will likely degrade at a faster rate due to movement and, perhaps, increased perspiration when the user's activity level is high. As such, the transmission controller may be configured to apply a transmission scheme with a lower frequency when the user is less active than when the user is more active to, perhaps, save power consumed by the second interface and/or better utilize the storage capacity of the memory.

In one or more exemplary monitor devices, the one or more control parameters comprises a control parameter indicative of connectivity between the monitor device and an accessory device. Connectivity refers to the capability of the monitor device to connect to one or more devices of the ostomy system, such as to the accessory device. A control parameter indicative of connectivity between the monitor device and an accessory device may comprise a connectivity indicator, which is configured to indicate whether the monitor device is able to connect to one or more devices of the ostomy system, and/or the type of transmission protocol or network available for connecting to the one or more devices of the ostomy system. For example, the transmission controller may control the transmission scheme by adjusting the transmission parameter (e.g. the amount of data to transmit, the transmission frequency, the transmission power, the transmission protocol or network) based on a connectivity indicator indicating the presence or absence of any communication/transmission protocol or network (e.g. Bluetooth, Bluetooth Low Energy, ZigBee, WLAN, cellular protocol or network, connection to the docking station).

In one or more exemplary monitor devices, the first transmission scheme comprises one or more criteria sets, each criteria set comprising one or more criteria to be applied in the first transmission scheme. A criteria set may comprise first criteria, second criteria, and/or third criteria. The first criteria may comprise a first primary criterion based on first parameter data, such as a resistance between respective electrodes of a first sensor. The first primary criterion may be based on second parameter data and/or the third parameter data. The first criteria may comprise a first secondary criterion based on the second parameter data. The first secondary criterion may be based on the first parameter data and/or third parameter data. The first criteria may comprise a first tertiary criterion based on the third parameter data. The first tertiary criterion may be based on the first parameter data and/or the second parameter data. A first criterion, such as the first primary criterion, the first secondary criterion and/or the first tertiary criterion, may be based on one or more first threshold values. A first threshold value may be a constant, or fixed value, or may be dynamic and/or adaptive, i.e. vary or be changed during operation of the ostomy monitor device.

A criteria set may comprise power criteria, connectivity criteria, data size criteria, location criteria, temperature criteria.

For example, the transmission controller may be configured to determine the transmission scheme based on the power capacity by reducing a transmission frequency (from a first transmission frequency to a second transmission frequency smaller than the first transmission frequency; or from a first transmission periodicity to a second transmission periodicity larger than the first transmission periodicity) when the power capacity of the power unit is determined by the transmission controller to be below a first power threshold.

For example, the transmission controller may be configured to determine the transmission scheme based on the power capacity by reducing transmission power (from a first transmission power to a second transmission power lower than the first transmission power) when the power capacity of the power unit is determined by the transmission controller to be below a second power threshold.

For example, the transmission controller may be configured to determine the transmission scheme based on the power capacity by increasing transmission power (from a first transmission power to a second transmission power higher than the first transmission power) when the power capacity of the power unit is determined by the transmission controller to be above a third power threshold.

In one or more exemplary monitor devices, the first, second, and third power threshold may be the same. In one or more exemplary monitor devices, any two of the first, second, and third power threshold may be different.

For example, the transmission controller may be configured to determine the transmission scheme based on the connectivity by reducing transmission power (from a first transmission power to a second transmission power lower than the first transmission power) when the control parameter indicative of the connectivity indicates high connectivity, such as connectivity to a local area network with e.g. a signal-to-noise ration of received signal above a threshold.

In one or more exemplary monitor devices, the one or more control parameters comprises a control parameter indicative of a temperature of the monitor device and/or of the ostomy appliance. Temperature may be indicative of the environment in which the monitor device and/or ostomy appliance is present. For example, temperature may be indicative of the monitor device being worn by the user and/or the ostomy appliance being worn by the user. For example, temperature may be indicative of the monitor device being worn by the user indoor or outdoor, and/or the ostomy appliance being worn by the user indoor or outdoor. In one or more exemplary monitor devices, the monitor device comprises a sensor unit connected to the processor. The sensor unit may comprise a temperature sensor for feeding temperature data to the processor and/or a G-sensor or accelerometer for feeding acceleration data to the processor. In one or more exemplary monitor devices, the control parameter indicative of the activity level of the user and/or the control parameter indicative of a temperature of the monitor device and/or of the ostomy appliance may be determined by the sensor unit, and provided to the transmission controller.

In one or more monitor devices, the transmission controller may be configured to control the transmission scheme based on one or more control parameters indicative of an orientation of the user of the ostomy appliance. For example, if the user is standing up, monitor data may be transmitted at a higher rate than if the user was lying down. The reason is because the adhesion between the first adhesive layer and the skin surface of the user will likely degrade at a faster rate due to movement and, perhaps, increased perspiration when the user is standing up. As such, the transmission controller may transmit monitor data at a lower frequency when the user is lying down than standing up to, perhaps, save power consumed by the second interface and/or better utilize the storage capacity of the memory. In one or more exemplary monitor devices, the control parameter indicative of the orientation of the user may be determined by the sensor unit, e.g. a G-sensor or accelerometer.

In one or more exemplary monitor devices, the first transmission scheme comprises a parameter data configuration indicative of parameter data to be transmitted in the first transmission scheme. A parameter data configuration indicative of parameter data to be transmitted in a transmission scheme may comprise a parameter data configuration identifier of which parameter data to transmit. In other words, the parameter data configuration identifier identifies (and/or defines) the type of (and/or the set of) parameter data that is to be transmitted in the transmission scheme.

In one or more exemplary monitor devices, the first transmission scheme comprises an ostomy data configuration indicative of ostomy data to be transmitted in the first transmission scheme. An ostomy data configuration indicative of ostomy data to be transmitted in a transmission scheme may comprise an ostomy data configuration identifier of which ostomy data to transmit. In other words, the ostomy data configuration identifier identifies (and/or defines) the type of (and/or the set of) ostomy data that is to be transmitted in the transmission scheme.

In one or more exemplary monitor devices, to control the transmission scheme comprises to determine a parameter data configuration and/or an ostomy data configuration of the first transmission scheme based on the one or more control parameters. In other words, to control the transmission scheme comprises to select parameter data and/or ostomy data to be transmitted based on based on the one or more control parameters disclosed herein.

In one or more exemplary ostomy systems, the monitor device forms an integrated part of the ostomy appliance, e.g. the monitor device may form an integrated part of a base plate of the ostomy appliance.

The present disclosure provides a method of monitoring an ostomy appliance with a monitor device. The monitor device comprises a processor; memory; and a first interface connected to the processor and the memory and a second interface configured for connecting to one or more accessory devices. The first interface comprises a plurality of terminals including a ground terminal and a first terminal. The second interface comprises a transceiver connected to the processor for transmitting monitor data. The method comprises obtaining monitor data based on ostomy data and/or parameter data of the ostomy appliance. The method comprises controlling transmission of the monitor data according to a transmission scheme. Controlling the transmission of the monitor data may comprise applying a primary transmission scheme or a secondary transmission scheme different from the primary transmission scheme.

The present disclosure provides an ostomy appliance system comprising an ostomy appliance and a monitor device according to this disclosure wherein the ostomy appliance comprises a base plate. The ostomy system may comprise a docking station forming an accessory device of the ostomy system. The docking station may be configured to electrically and/or mechanically couple the monitor device to the docking station.

The docking station may comprise a docking monitor interface. The docking monitor interface may be configured for electrically and/or mechanically connecting the monitor device to the docking station. The docking monitor interface may be configured for wirelessly connecting the monitor device to the docking station. The docking monitor interface of the docking station may be configured to electrically and/or mechanically couple the docking station and the monitor device.

The docking monitor interface of the docking station may comprise, e.g. as part of a first connector of the docking monitor interface, a coupling part for forming a mechanical connection, such as a releasable coupling between the monitor device and the docking station. The coupling part may be configured to engage with a coupling part of the monitor device for releasably coupling the monitor device to the docking station.

The docking monitor interface of the docking station may comprise, e.g. as part of a first connector of the docking monitor interface, a plurality of terminals, such as two, three, four, five, six, seven or more terminals, for forming electrical connections with respective terminals of the monitor device. The docking monitor interface may comprise a ground terminal. The docking monitor interface may comprise a first terminal and/or a second terminal. The docking station may comprise a third terminal. The docking monitor interface may comprise a fourth terminal and/or a fifth terminal. The docking monitor interface optionally comprises a sixth terminal.

FIG. 1 illustrates an exemplary ostomy system. The ostomy system 1 comprises an ostomy appliance 2 including a base plate 4 and an ostomy pouch (not shown). Further, the ostomy system 1 comprises a monitor device 6 and an accessory device 8 (mobile telephone). The monitor device 6 is connectable to the base plate 4 via respective first connectors of the monitor device 6 and base plate 4. The monitor device 6 is configured for wireless communication with the accessory device 8. Optionally, the accessory device 8 is configured to communicate with a server device 10 of the ostomy system 1, e.g. via network 12. The server device 10 may be operated and/or controlled by the ostomy appliance manufacturer and/or a service centre. Ostomy data or parameter data based on the ostomy data are obtained from electrodes/sensors of the ostomy appliance 2 with the monitor device 6. The monitor device 6 processes the ostomy data and/or parameter data based on the ostomy data to determine monitor data that are transmitted to the accessory device 8. In the illustrated ostomy system, the accessory device 8 is a mobile phone, however the accessory device 8 may be embodied as another handheld device, such as a tablet device, or a wearable, such as a watch or other wrist-worn electronic device.

Accordingly, the monitor device 6 is configured to determine and transmit monitor data to the accessory device 8. The base plate 4 comprises a coupling member 14 in the form of a coupling ring 16 for coupling an ostomy pouch (not shown) to the base plate (two-part ostomy appliance). The base plate has a stoma-receiving opening 18 with a stoma center point. The size and/or shape of the stomal opening 18 is typically adjusted by the user or nurse before application of the ostomy appliance to accommodate the user's stoma.

The ostomy system 1 optionally comprises a docking station 20 forming an accessory device of the ostomy system 1. The docking station 20 comprises a docking monitor interface including a first connector 22 configured for electrically and/or mechanically connecting the monitor device 6 to the docking station 20. The docking monitor interface may be configured for wirelessly connecting the monitor device to the docking station. The docking station 20 comprises a user interface 24 for receiving user input and/or providing feedback to the user on the operational state of the docking station 20. The user interface 24 may comprise a touch-screen. The user interface 24 may comprise one or more physical buttons and/or one or more visual indicators, such as light emitting diodes,

FIG. 2 is a schematic block diagram of an exemplary monitor device. The monitor device 6 comprises a monitor device housing 100, a processor 101, and one or more interfaces, the one or more interfaces including a first interface 102 (appliance interface) and a second interface 104 (accessory interface). The monitor device 6 comprises a memory 106 for storing ostomy data and/or parameter data based on the ostomy data. The memory 106 is connected to the processor 101 and/or the first interface 102.

The first interface 102 is configured as an appliance interface for electrically and/or mechanically connecting the monitor device 6 to the ostomy appliance, e.g. ostomy appliance 2. The first interface 102 comprises a plurality of terminals for forming electrical connections with respective terminals of the ostomy appliance 2 (base plate 4). The first interface 102 comprises a ground terminal 108, a first terminal 110, a second terminal 112 and a third terminal 114. The first interface 102 optionally comprises a fourth terminal 116 and a fifth terminal 118. The first interface 102 of the monitor device 6 comprises a coupling part 120 for forming a mechanical connection, such as a releasable coupling between the monitor device and the base plate. The coupling part 120 and the terminals 108, 110, 112, 114, 116, and 118 of the first interface 102 form (at least part of) a first connector of the monitor device 6.

The monitor device 6 comprises a power unit 121 for powering the monitor device and active components thereof, i.e. the power unit 121 is connected to the processor 101, the first interface 102, the second interface 104, and memory 106. The power unit comprises a battery and charging circuitry. The charging circuitry is connected to the battery and terminals of the first interface 102 for charging the battery via terminals of the first interface, e.g. terminals of the first connector.

The second interface 104 of monitor device is configured as an accessory interface for connecting the monitor device 6 to one or more accessory devices such as accessory device 8. The second interface 104 comprises an antenna 122 and a wireless transceiver 124 configured for wireless communication with accessory device(s). Optionally, the second interface 104 comprises a loudspeaker 126 and/or a haptic feedback element 128 for provision of respective audio signal and/or haptic feedback to the user.

The monitor device 6 comprises a sensor unit 140 connected to the processor 101. The sensor unit 140 comprises a temperature sensor for feeding temperature data to the processor and a G-sensor or accelerometer for feeding acceleration data to the processor 101.

The processor 101 is configured to apply a processing scheme, and the first interface 102 is configured for collecting ostomy data from the base plate coupled to the first interface, the ostomy data comprising first ostomy data from a first electrode pair of the base plate, second ostomy data from a second electrode pair of the base plate, and third ostomy data from a third electrode pair of the base plate. The ostomy data may be stored in the memory 106 and/or processed in the processor 101 in order to obtain parameter data. The parameter data may be stored in the memory 106. The processor 101 is configured to apply a processing scheme, wherein to apply a processing scheme comprises obtain first parameter data based on the first ostomy data; obtain second parameter data based on the second ostomy data; obtain third parameter data based on the third ostomy data. In other words, the processor 101 is configured to obtain first, second and third parameter data based on respective first, second and third ostomy data. To apply a processing scheme comprises to determine an operating state of the base plate of the ostomy appliance based on one or more, e.g. all, of the first parameter data, the second parameter data and the third parameter data, wherein the operating state is indicative of a degree of radial erosion of the base plate and/or acute leakage risk for the ostomy appliance. The monitor device 6 is configured to, in accordance with a determination that the operating state is a first operating state, transmit a first monitor signal comprising monitor data indicative of the first operating state of the base plate via the second interface; and in accordance with a determination that the operating state is a second operating state, transmit a second monitor signal comprising monitor data indicative of the second operating state of the base plate via the second interface.

FIG. 3 illustrates an exploded view of an exemplary base plate of an ostomy appliance. The base plate 4 comprises a first adhesive layer 200. During use, a proximal surface of the first adhesive layer 200 adheres to the user's skin in the peristomal area and/or to additional seals, such as sealing paste, sealing tape and/or sealing ring. The base plate 4 optionally comprises a second adhesive layer 202, also denoted rim adhesive layer. The base plate 4 comprises a plurality of electrodes arranged in an electrode assembly 204.

The electrode assembly 204 is arranged between the first adhesive layer 200 and the second adhesive layer 202. The electrode assembly 204 comprises a support layer with electrodes formed on a proximal surface of the support layer. The base plate 4 comprises a release liner 206 that is peeled off by the user prior to applying the base plate 4 on the skin. The base plate 4 comprises a top layer 208 and a coupling ring 209 for coupling an ostomy pouch to the base plate 4. The top layer 208 is a protective layer protecting the second adhesive layer 202 from external strains and stress during use.

The base plate 4 comprises a monitor interface. The monitor interface is configured for electrically and/or mechanically connecting the ostomy appliance (base plate 4) to the monitor device. The monitor interface of the base plate comprises a coupling part 210 for forming a mechanical connection, such as a releasable coupling between the monitor device and the base plate. The coupling part 210 is configured to engage with a coupling part of the monitor device for releasably coupling the monitor device to the base plate 4. Further, the monitor interface of the base plate 4 comprises a plurality of terminal elements respectively forming a plurality of terminals 212 for forming electrical connections with respective terminals of the monitor device. The coupling part 210 and the terminals 212 form a first connector 211 of the base plate 4. The base plate 4 comprises a first intermediate element 213 on the distal side of the electrode assembly. The first intermediate element 213 is arranged between the terminal elements forming terminals 212 and the first adhesive layer (not shown). The first intermediate element 213 covers the terminal elements forming terminals 212 of the base plate 4 when seen in the axial direction and protects the first adhesive layer from mechanical stress from the terminal elements of the base plate.

FIG. 4 illustrates an exploded view of an exemplary electrode assembly 204 of a base plate. The electrode assembly 204 comprises a support layer 214 with proximal surface 214B and electrodes 216 arranged on the proximal side of the support layer 214 and including a ground electrode, a first electrode, a second electrode, a third electrode, a fourth electrode, and a fifth electrode, wherein each electrode has a respective connection part for connecting the electrodes to respective terminal elements of the monitor interface. Further, electrode assembly 204 comprises a masking element 218 with proximal surface 218B and configured to insulate electrode parts of electrodes 216 from the first adhesive layer of the base plate. The masking element 218 covers or overlap with parts of the electrodes 216 when seen in the axial direction.

FIG. 5 is a proximal view of proximal surfaces of base plate parts of the base plate without the first adhesive layer and the release liner. The base plate 4 comprises a first intermediate element 213 on the distal side of the electrode assembly, i.e. between the electrode assembly 204 and the first adhesive layer (not shown). The first intermediate element 213 covers the terminal elements of the base plate 4 when seen in the axial direction and protects the first adhesive layer from mechanical stress from the terminal elements of the base plate.

FIG. 6 is a distal view of an exemplary electrode configuration 220 of electrodes 216 of the electrode assembly 204. The electrode configuration 220/electrode assembly 204 comprises a ground electrode 222, a first electrode 224, a second electrode 226, a third electrode 228, a fourth electrode 230, and a fifth electrode 232. The ground electrode 222 comprises a ground connection part 222A and the first electrode 224 comprises a first connection part 224A. The second electrode 226 comprises a second connection part 226A and the third electrode 228 comprises a third connection part 228A. The fourth electrode 230 comprises a fourth connection part 230A and the fifth electrode 232 comprise a fifth connection part 232A.

The fourth electrode 230 comprises fourth sensing parts 230B. The fifth electrode 232 comprises fifth sensing parts 232B.

The ground electrode 222 comprises a first electrode part 234 for forming a ground for the first electrode 224. The ground electrode 222 comprises a second electrode part 236 for forming a ground for the second electrode 226. The ground electrode 222 comprises a third electrode part 238 for forming a ground for the third electrode 228. The ground electrode 222 comprises a fourth electrode part 240 for forming a ground for the fourth electrode 230 and the fifth electrode 232. The fourth electrode part 240 of the ground electrode 222 comprises ground sensing parts 222B

FIG. 7 is a distal view of an exemplary masking element. The masking element 218 optionally has a plurality of terminal openings including six terminal openings. The plurality of terminal openings comprises a ground terminal opening 242, a first terminal opening 244, a second terminal opening 246, a third terminal opening 248, a fourth terminal opening 250, and a fifth terminal opening 252. The terminal openings 242, 244, 246, 248, 250, 252 of the masking element 218 are configured to overlap and/or be aligned with respective connection parts 222A, 224A, 226A, 228A, 230A, 232A of the electrodes of the electrode assembly.

The masking element 218 has a plurality of sensor point openings. The sensor point openings comprise primary sensor point openings shown within dotted line 254, each primary sensor point opening configured to overlap a part of the ground electrode 222 and/or a part of the fourth electrode 230. The primary sensor point openings 254 comprise, in the illustrated exemplary masking element, five primary first sensor point openings 254A each configured to overlap a part of the ground electrode 222. The primary sensor point openings 254 comprise, in the illustrated exemplary masking element, four primary second sensor point openings 254B each configured to overlap a part of the fourth electrode 230. The sensor point openings comprise secondary sensor point openings shown within dotted line 256, each second sensor point opening configured to overlap a part of the fourth electrode 230 and/or a part of the fifth electrode 232. The secondary sensor point openings 256 comprise, in the illustrated exemplary masking element, five secondary first sensor point openings 256A each configured to overlap a part of the fifth electrode 232. The secondary sensor point openings 256 comprise, in the illustrated exemplary masking element, four secondary second sensor point openings 256B each configured to overlap a part of the fourth electrode 230. The sensor point openings comprise tertiary sensor point openings shown within dotted line 258, each tertiary sensor opening configured to overlap a part of the fifth electrode 232 and/or a part of the ground electrode 222. The tertiary sensor point openings 258 comprise, in the illustrated exemplary masking element, five tertiary first sensor point openings 258A each configured to overlap a part of the fifth electrode 232. The tertiary sensor point openings 258 comprise, in the illustrated exemplary masking element, four tertiary second sensor point openings 258B each configured to overlap a part of the ground electrode 222.

FIG. 8 is a distal view of an exemplary first adhesive layer. The first adhesive layer 200 has a plurality of sensor point openings. The sensor point openings of the first adhesive layer comprise primary sensor point openings shown within dotted line 260, each primary sensor point opening configured to overlap a part of the ground electrode 222 and/or a part of the fourth electrode 230 of the electrode assembly. The primary sensor point openings 260 comprise, in the illustrated exemplary first adhesive layer, five primary first sensor point openings 260A each configured to overlap a part of the ground electrode 222. The primary sensor point openings 260 comprise, in the illustrated exemplary first adhesive layer, four primary second sensor point openings 260B each configured to overlap a part of the fourth electrode 230. The sensor point openings of the first adhesive layer comprise secondary sensor point openings shown within dotted line 262, each second sensor point opening configured to overlap a part of the fourth electrode 230 and/or a part of the fifth electrode 232 of the electrode assembly. The secondary sensor point openings 262 comprise, in the illustrated exemplary first adhesive layer, five secondary first sensor point openings 262A each configured to overlap a part of the fifth electrode 232. The secondary sensor point openings 262 comprise, in the illustrated exemplary first adhesive layer, four secondary second sensor point openings 262B each configured to overlap a part of the fourth electrode 230.The sensor point openings of the first adhesive layer comprise tertiary sensor point openings shown within dotted line 264, each tertiary sensor opening configured to overlap a part of the fifth electrode 232 and/or a part of the ground electrode 222 of the electrode assembly. The tertiary sensor point openings 264 comprise, in the illustrated exemplary first adhesive layer, five tertiary first sensor point openings 264A each configured to overlap a part of the fifth electrode 232. The tertiary sensor point openings 264 comprise, in the illustrated exemplary first adhesive layer, four tertiary second sensor point openings 264B each configured to overlap a part of the ground electrode 222. FIG. 9 is a proximal view of the first adhesive layer of FIG. 8.

FIG. 10 is a more detailed distal view of a part of the base plate 4. Monitor interface of the base plate comprises the first connector 211. The first connector 211 comprises coupling part 210 configured to releasably couple the monitor device to the base plate and thus forming a releasable coupling. The first connector 221/monitor interface comprises a plurality of terminals formed by respective terminal elements for forming respective electrical connections with respective terminals of the monitor device.

The plurality of terminals of the first connector 211/monitor interface comprises a ground terminal element 282 forming a ground terminal 282A, a first terminal element 284 forming a first terminal 284, a second terminal element 286 forming a second terminal 286A, and a third terminal element 288 forming a third terminal 288A. The monitor interface optionally comprises a fourth terminal element 290 forming a fourth terminal 290A and/or a fifth terminal element 292 forming a fifth terminal 290. The terminal elements 282, 284, 286, 288, 290, 292 contact respective connection parts 222A, 224A, 226A, 228A, 230 a, 232A of electrodes 222, 224, 226, 228, 230, 232.

The position of the first connector on the base plate, the number of terminals and the position of the terminals in the coupling part may be adapted to the electrode configuration used in the electrode assembly of the base plate.

FIG. 11 shows a block diagram of an exemplary monitor device 6 of the ostomy system 1. The monitor device 6 comprises a processor 101; memory 106; and a first interface 102 connected to the processor 101 and the memory 106.

The monitor device 6 comprises a monitor device housing 100, a processor 101, and one or more interfaces, the one or more interfaces including a first interface 102 (appliance interface) and a second interface 104 (accessory interface). The monitor device 6 comprises a memory 106 for storing ostomy data and/or parameter data based on the ostomy data. The memory 106 is connected to the processor 101 and/or the first interface 102. The first interface 102 is configured for connecting to an ostomy appliance (e.g. ostomy appliance 2 illustrated in FIG. 1). The first interface 102 is configured as an appliance interface for electrically and/or mechanically connecting the monitor device 6 to the ostomy appliance, e.g. ostomy appliance 2. The first interface 102 comprises a plurality of terminals for forming electrical connections with respective terminals of the ostomy appliance 2 (base plate 4). In embodiments, the first interface 102 comprises a ground terminal 108, a first terminal 110, a second terminal 112 and a third terminal 114. The first interface 102 may also comprise a fourth terminal 116 and a fifth terminal 118. The first interface 102 of the monitor device 6 comprises a coupling part 120 for forming a mechanical connection, such as a releasable coupling between the monitor device and the base plate. The coupling part 120 and the terminals 108, 110, 112, 114, 116, and 118 of the first interface 102 form (at least part of) a first connector of the monitor device 6.

The monitor device 6 comprises a power unit 121 for powering the monitor device and active components thereof, i.e. the power unit 121 is connected to the processor 101, the first interface 102, the second interface 104, and memory 106. The power unit comprises a battery and charging circuitry. The charging circuitry is connected to the battery and terminals of the first interface 102 for charging the battery via terminals of the first interface, e.g. terminals of the first connector.

The second interface 104 of monitor device comprises a transceiver 123 connected to the processor 101 for transmitting monitor data according to a transmission scheme. The second interface is configured for connecting to one or more accessory devices (e.g. accessory device 8 of FIG. 1).

The second interface 104 of monitor device is configured as an accessory interface for connecting the monitor device 6 to one or more accessory devices such as accessory device 8.

The second interface may comprise an antenna 122. The transceiver 123 may comprise a wireless transceiver 124 configured for wireless communication with accessory device(s). Optionally, the second interface 104 comprises a loudspeaker 126 and/or a haptic feedback element 128 for provision of respective audio signal and/or haptic feedback to the user.

The processor 101 comprises a transmission controller 130 configured to control the transmission scheme. The transmission controller 130 may be configured to control the transmission scheme by applying a primary transmission scheme or a secondary transmission scheme different from the primary transmission scheme. In one or more exemplary monitor devices, the transmission controller 130 is configured to determine the transmission scheme based on one or more control parameters. For example, the transmission controller 130 may be configured to determine the transmission scheme based on one or more control parameters by determining one or more control parameters and selecting the transmission scheme based on the one or more control parameters. The transmission controller 130 is connected the second interface 104, e.g. to the transceiver 123. The transmission 130 may configured to provide control signals to the second interface 104 (e.g. to the transceiver 123), where the control signals are indicative of which transmission scheme has been selected with respect to transmission parameters such as transmission power, transmission radio frequency, transmission phase (e.g. phase of radio signal), transmission protocol or network.

In one or more exemplary monitor devices, the first transmission scheme comprises a first transmission parameter. In one or more exemplary monitor devices, the second transmission scheme comprises a second transmission parameter. In one or more exemplary monitor devices, the first transmission parameter and the second transmission parameter are different. A transmission parameter may comprise a transmission frequency, a transmission periodicity, a transmission power, a transmission protocol and/or any combination thereof.

In one or more exemplary monitor devices, the transmission controller 130 may be configured to determine the transmission scheme based on one or more control parameters comprising a control parameter indicative of an operating state of the ostomy appliance. Embodiments of the operating state of the ostomy appliance 2 include, but are not limited to the following examples. The operating state may comprise N operating states, where N is an integer. The operating state may comprise a first operating state, a second operating state, a third operating state, a fourth operating state, a fifth operating state, a sixth operating state, and a default operating state. For example, an operating state may be reflecting by e.g. good, check, change in X time, change NOW. In one or more exemplary monitor devices, the operating state of the ostomy appliance 2 of FIG. 1 may be monitored by the processor 101 and, based on the operating state, it may be beneficial for the transmission controller 130 to select a specific transmission scheme based on, potentially different operating states.

The monitor device 6 comprises a sensor unit 140 connected to the processor 101. The sensor unit 140 comprises a temperature sensor for feeding temperature data to the processor and a G-sensor or accelerometer for feeding acceleration data to the processor 101.

In one or more exemplary monitor devices, the transmission controller 130 may be configured to determine the transmission scheme based on one or more control parameters comprising a control parameter indicative of a power capacity of a power unit 121 of the monitor device 6. The monitor device 6 comprises a power unit 121 for powering the monitor device 6. The power unit may comprise a battery. The power unit 121 may comprise charging circuitry connected to the battery and terminals of the first interface for charging the battery via the first interface, e.g. the first connector. The first interface may comprise separate charging terminal(s) for charging the battery. The power unit 121 has a power capacity, such as a power capacity at the time of the control of the transmission scheme, such as a current power capacity of the power unit 121 of the monitor device 6. For example, if the power capacity of the power unit 121 is below a threshold, then monitor data may be transmitted according to a second transmission scheme having a second transmission parameter that is a lower rate than if the power capacity of the power unit 121 is above a threshold. The reason being is because, in embodiments, the transmission controller 130 may be more likely to run out of power and, therefore, be unable to provide indications of the quality of adhesion between the first adhesive layer 200 and the skin surface of the user and/or whether output is leaking between the first adhesive layer 200 and the skin surface of the user, if the power consumed by transmission controller when applying the first scheme is higher than the power consumed by transmission controller when applying the second scheme. In embodiments, the power capacity of the power unit 121 may be determined by the transmission controller 130. Additionally, or alternatively, the power capacity of the power unit 121 may be determined by the processor 101. Additionally, or alternatively, the transmission controller 130 may be configured to determine the transmission scheme based on a power capacity of the power unit 121.

In one or more exemplary monitor devices, the transmission controller 130 may be configured to determine the transmission scheme based on one or more control parameters comprising a control parameter indicative of an appliance model of the ostomy appliance (e.g. ostomy appliance 2 of FIG. 1). A control parameter indicative of an appliance model of the ostomy appliance may comprise an appliance model identifier, such as a serial number, such as a product line name. For example, some appliance models of an ostomy appliance 2 may have better or worse adhesion between the first adhesive layer 200 and the skin surface of the user. As such, the transmission controller 130 may be configured to determine a transmission scheme that transmit more frequently for appliance models having worse adhesion to allow timely detection of a leak.

Alternatively, the transmission controller 130 may be configured to transmit monitor data at a lower frequency (or higher periodicity) when the model type is one in which the adhesion characteristics are better than another model type. By transmitting monitor data at a lower frequency or higher periodicity, power consumed by the transmission controller 130 may be reduced and/or the storage capacity of the memory 103 may be better utilized. In embodiments, the appliance model of the ostomy appliance 2 may be input into the processor 101, sensed by the sensor unit 140, and/or the like.

In one or more exemplary monitor devices, the transmission controller 130 may be configured to determine the transmission scheme based on one or more control parameters comprising a control parameter indicative of a data collection scheme of the monitor device 6. Each data collection scheme may have one or more data collection parameters (e.g. amount of data to be collected, data collection frequency, data type). A control parameter indicative of a data collection scheme may comprise a data collection scheme identifier that uniquely identifies a data collection scheme amongst a plurality of data collection schemes. The transmission controller 130 may be configured to determine the transmission scheme based on the data collection scheme identifier. The transmission controller 130 may be configured to adjust a transmission parameter of a transmission scheme based on one or more data collection parameters (e.g. amount of data to be collected, data collection frequency, data type). For example, the transmission frequency may be determined based on the data collection frequency. The processor 101 may be configured to determine the data collection scheme identifier and may be configured to provide the data collection scheme identifier. This may have the advantage of exploiting the synergy between data collection and data transmission of the monitor data, and thereby optimizing usage of memory storage of memory 106.

In one or more exemplary monitor devices, the transmission controller 130 may be configured to determine the transmission scheme based on one or more control parameters comprising a control parameter indicative of a data processing scheme of the monitor device 6. A control parameter indicative of a data processing scheme may comprise a data processing scheme identifier that identifies a data processing scheme amongst a plurality of data processing schemes, wherein each data processing scheme has one or more data processing parameters (e.g. what parameter data is to be generated, what ostomy data is to be used to generate the parameter data, the function to be applied on the ostomy data, data processing frequency (i.e. how often ostomy data is processed to generate parameter data and/or monitor data)). The transmission controller 130 may be configured to determine the transmission scheme based on the data processing scheme identifier. The transmission controller 130 may be configured to adjust a transmission parameter of a transmission scheme based on one or more data processing parameters. For example, the transmission parameters may be determined based on the data processing scheme frequency, what parameter data is to be generated, and/or what ostomy data is to be used to generate the parameter data. The processor may be configured to determine the data processing scheme identifier and may be configured to provide the data collection processing identifier. This may have the advantage of exploiting the synergy between data processing and data transmission of the monitor data, and thereby optimizing usage of memory storage of memory 106 as well as usage of the power capacity of the power unit 121.

In one or more exemplary monitor devices, the transmission controller 130 may be configured to determine the transmission scheme based on one or more control parameters comprising a control parameter indicative of size of ostomy data and/or of the size of monitor data in the memory 106. The transmission controller 130 may be configured to adjust a transmission parameter of a transmission scheme based on the size of any one or more of ostomy data, parameter data, monitor data. For example, the transmission controller 130 may be configured to apply a first transmission scheme by transmitting a first monitor data set with a first data size. For example, the transmission controller 130 may be configured to apply a second transmission scheme by transmitting a second monitor data set with a second data size different from the first data size, e.g. to reduce data size (e.g. when the power unit 121 indicate a low power, e.g. below a power threshold). The second transmission scheme may be a data dump transmission scheme, where the memory 106 is emptied from monitor data in its entirety, e.g. when the second interface 104 has detected that the monitor device is plugged into the docking station (e.g. docking station 20 of FIG. 1).

In one or more exemplary monitor devices, the transmission controller 130 may be configured to determine the transmission scheme based on one or more control parameters comprising a control parameter indicative of a wear time of the ostomy appliance (e.g. ostomy appliance 2 of FIG. 1). For example, when the user has been wearing the ostomy appliance 2 for a period of time that exceeds a threshold, data may be transmitted at a higher rate than if the wear time is less than the threshold. The transmission controller 130 may determine a second transmission scheme having a higher frequency than the first transmission scheme for transmitting the monitor data. An advantage of transmitting data according to such a second transmission scheme when the wear time is greater than a threshold is that it permits to anticipate that the adhesion between the first adhesive layer 200 and the skin surface of the user will likely degrade over time and to anticipate a leakage. As such, the transmission controller 130 may be configured to transmit the monitor data according to a second transmission scheme having a higher frequency when the wear time of the ostomy appliance 2 has surpassed a threshold. In embodiments, the processor 101 or the transmission controller 130 may be configured determine whether the wear time has surpassed the threshold. Additionally, or alternatively, the threshold may be input into the monitor device 6 and/or based on a previous wear time of the ostomy appliance 2 by the user, and/or based on the appliance model of the ostomy appliance 2.

In one or more exemplary monitor devices, the transmission controller 130 may be configured to determine the transmission scheme based on one or more control parameters comprising a control parameter indicative of preferences of a user of the ostomy appliance (e.g. ostomy appliance 2 of FIG. 1). For example, when the user has a preference that he/she would like to know within a period of time that the adhesion between the first adhesive layer 200 and the skin surface of the user degrades below a threshold amount, that preference may be communicated via a control signal provided by the processor 101 to the transmission controller 130. In response, the transmission controller 130 may be configured to determine the transmission scheme with a transmission frequency which allows monitor data to be transmitted within a period of time before degradation of the adhesion. In embodiments, to determine the transmission scheme based on a control parameter indicative of preferences of a user of the ostomy appliance may provide piece of mind for the user, and improve the quality of life of the user of the ostomy appliance.

In one or more exemplary monitor devices, the transmission controller 130 may be configured to determine the transmission scheme based on one or more control parameters comprising a control parameter indicative of a location of a user of the ostomy appliance (e.g. ostomy appliance 2 of FIG. 1). For example, users of ostomy appliances 2 may differ in their ostomy habits based on the location of the users. For example, users in a first country may change their ostomy appliances 2 more frequently than users in a second country due to, perhaps, better healthcare subsidies. As such, users in the first country may wish to have quicker notifications of adhesion degradation than users in the second country. Accordingly, the transmission controller 130 may implement a data transmission scheme that transmits data at a higher frequency for users in the first country so that a determination as to the degradation of the adhesion can be made more often and, therefore, quicker notifications about adhesion degradation can be provided.

Additionally, or alternatively, the transmission controller may control the transmission scheme by adjusting the transmission parameter (e.g. the amount of data to transmit, the transmission power, the transmission protocol) based on the location information (e.g. when indoor location is determined).

In one or more exemplary monitor devices, the transmission controller 130 may be configured to determine the transmission scheme based on one or more control parameters comprising a control parameter indicative of an activity level of a user (of e.g. ostomy appliance 2 of FIG. 1). For example, if the user's activity level is high (e.g., when the use is running), the transmission controller 130 may determine a transmission scheme with a higher transmission rate (e.g. throughput) than if the user is being less active. As such, the transmission controller 130 may be configured to select transmission schemes with a lower frequency when the user is less active than when the user is more active to, e.g., save power consumed by the transmission controller 130 and/or better utilize the storage capacity of the memory 106. In embodiments, the activity level of the user may be determined by the sensor unit 140.

In one or more exemplary monitor devices, the transmission controller 130 may be configured to determine the transmission scheme based on one or more control parameters comprising a control parameter indicative of connectivity between the monitor device and an accessory device. Connectivity refers to the capability of the monitor device to connect to one or more devices of the ostomy system, such as to the accessory device.

A control parameter indicative of connectivity between the monitor device and an accessory device may comprise a connectivity indicator, which is configured to indicate whether the monitor device is able to connect to one or more devices of the ostomy system, and/or the type of transmission protocol or network available for connecting to the one or more devices of the ostomy system. For example, the transmission controller may control the transmission scheme by adjusting the transmission parameter (e.g. the amount of data to transmit, the transmission frequency, the transmission power, the transmission protocol or network) based on a connectivity indicator indicating the presence or absence of any communication/transmission protocol or network (e.g. Bluetooth, Bluetooth Low Energy, ZigBee, WLAN, cellular protocol or network, connection to the docking station).

In one or more exemplary monitor devices, the first transmission scheme comprises one or more criteria sets, each criteria set comprising one or more criteria to be applied in the first transmission scheme. A criteria set may comprise first criteria, second criteria, and/or third criteria. The first criteria may comprise a first primary criterion based on first parameter data, such as a resistance between respective electrodes of a first sensor. The first primary criterion may be based on second parameter data and/or the third parameter data. The first criteria may comprise a first secondary criterion based on the second parameter data. The first secondary criterion may be based on the first parameter data and/or third parameter data. The first criteria may comprise a first tertiary criterion based on the third parameter data. The first tertiary criterion may be based on the first parameter data and/or the second parameter data. A first criterion, such as the first primary criterion, the first secondary criterion and/or the first tertiary criterion, may be based on one or more first threshold values. A first threshold value may be a constant, or fixed value, or may be dynamic and/or adaptive, i.e. vary or be changed during operation of the ostomy monitor device.

In one or more exemplary monitor devices, the transmission controller 130 may be configured to determine the transmission scheme based on one or more control parameters comprising a control parameter indicative of a temperature of the monitor device 6 and/or of the ostomy appliance (e.g. ostomy appliance 2 of FIG. 1). For example, temperature may be indicative of the monitor device 6 being worn by the user and/or the ostomy appliance 2 being worn by the user. For example, temperature may be indicative of the monitor device 6 being worn by the user indoor or outdoor, and/or the ostomy appliance 2 being worn by the user indoor or outdoor. In one or more exemplary monitor devices, the monitor device 6 comprises a sensor unit 140 connected to the processor 101. The sensor unit 140 may comprise a temperature sensor for feeding temperature data to the processor and/or a G-sensor or accelerometer for feeding acceleration data to the processor.

In one or more exemplary monitor devices, the first transmission scheme comprises a parameter data configuration indicative of parameter data to be transmitted in the first transmission scheme. A parameter data configuration indicative of parameter data to be transmitted in a transmission scheme may comprise a parameter data configuration identifier of which parameter data to transmit. The transmission controller 130 may be configured to apply the first transmission scheme comprising comprise a parameter data configuration identifier of which parameter data to transmit.

In one or more exemplary monitor devices, the first transmission scheme comprises an ostomy data configuration indicative of ostomy data to be transmitted in the first transmission scheme. An ostomy data configuration indicative of ostomy data to be transmitted in a transmission scheme may comprise an ostomy data configuration identifier of which ostomy data to transmit. The transmission controller 130 may be configured to apply the first transmission scheme comprising comprise an ostomy data configuration identifier of which ostomy data to transmit.

In embodiments, the functions performed by the transmission controller 130 may be performed by the processor 101 and/or the functions performed by the processor 101 may be performed by the transmission controller 130.

FIG. 12 illustrates a flow diagram of a method 300 of monitoring an ostomy appliance with a monitor device (e.g. monitor device 6).

To facilitate describing method 300, reference is made to the other figures, in particular, FIGS. 1, 2, 6, and 11: the monitor device 6 comprises a processor 101; memory 106; and a first interface 102 connected to the processor 101 and the memory 106 and a second interface 104 configured for connecting to one or more accessory devices (e.g. accessory device 8 and/or docking station 20). The first interface 102 comprises a plurality of terminals including a ground terminal and a first terminal. The second interface 104 comprises a transceiver 123 connected to the processor 101 for transmitting monitor data.

The method 300 comprises obtaining 301 monitor data based on ostomy data and/or parameter data of the ostomy appliance. The method comprises 302 controlling transmission of the monitor data according to a transmission scheme. Controlling 302 the transmission of the monitor data may comprise applying 302 a a primary transmission scheme or a secondary transmission scheme different from the primary transmission scheme.

Controlling 302 the transmission of the monitor data may comprise determining 302 b the transmission scheme based on one or more control parameters. In one or more exemplary methods, the one or more control parameters comprise a control parameter indicative of an operating state of the ostomy appliance. In one or more exemplary methods, the one or more control parameters comprises a control parameter indicative of a power capacity of a power unit of the monitor device. In one or more exemplary methods, the one or more control parameters comprises a control parameter indicative of an appliance model of the ostomy appliance. In one or more exemplary methods, the one or more control parameters comprises a control parameter indicative of a data collection scheme of the monitor device. In one or more exemplary methods, the one or more control parameters comprises a control parameter indicative of a data processing scheme of the monitor device. In one or more exemplary methods, the one or more control parameters comprises a control parameter indicative of size of ostomy data and/or of the size of monitor data in the memory. In one or more exemplary methods, the one or more control parameters comprises a control parameter indicative of a wear time of the ostomy appliance. In one or more exemplary methods, the one or more control parameters comprises a control parameter indicative of preferences of a user of the ostomy appliance. In one or more exemplary methods, the one or more control parameters comprises a control parameter indicative of a location of a user of the ostomy appliance. In one or more exemplary methods, the one or more control parameters comprises a control parameter indicative of an activity level of a user. In one or more exemplary methods, the one or more control parameters comprises a control parameter indicative of connectivity between the monitor device and an accessory device. In one or more exemplary methods, the one or more control parameters comprises a control parameter indicative of a temperature of the monitor device and/or of the ostomy appliance.

Controlling 302 the transmission of the monitor data may comprise determining 302 c a parameter data configuration and/or an ostomy data configuration of the first transmission scheme based on the one or more control parameters.

FIG. 13 shows an exemplary graphical representation of parameter data as a function of time. In this example, the parameter data in the y-axis is in Volts and time is in the x-axis.

Curve 1100 shows, as a function of time, first parameter data indicative of voltage measured by the first electrode pair of the base plate. Curve 1102 shows, as a function of time, second parameter data indicative of voltage measured by the second electrode pair of the base plate. Curve 1104 shows, as a function of time, third parameter data indicative of voltage measured by the third electrode pair of the base plate. Curves 1108, 1116, 1118 show, as a function of time, fourth primary parameter indicative of voltage measured by the fourth electrode pair of the base plate, fourth secondary parameter indicative of voltage measured by the fourth electrode and the fifth electrode of the base plate, and fourth tertiary parameter indicative of voltage measured by the fifth electrode pair of the base plate respectively. Curves 1110, 1112, 1114 show, as a function of time, a gradient of fourth primary parameter indicative of voltage gradient measured by the fourth electrode pair of the base plate, a gradient of fourth secondary parameter indicative of voltage gradient measured by the fourth electrode and the fifth electrode of the base plate, and a gradient of fourth tertiary parameter indicative of voltage gradient measured by the fifth electrode pair of the base plate respectively. FIG. 13 shows the upper voltage threshold value represented as curve 1000, the medium voltage threshold value represented as curve 1002, the lower voltage threshold value represented as curve 1004, and curve 1006 is a gradient limit.

Curves 1108, 1116, 1118 as well as curves 1110, 1112, 1114 show that no moisture is detected at the proximal side of the first adhesive layer by the fourth electrode pair.

At a time less than 5 h, curve 1100 shows that moisture is detected by the first electrode pair as the first parameter data crosses the upper voltage threshold value while curve 1102 shows that moisture is not detected by the second electrode pair as the second parameter data has not crossed the upper voltage threshold value. At this stage, it is determined that the ostomy appliance is in a first operating state.

At time between 5 h and 10 h, curve 1102 shows that moisture is detected by the second electrode pair as the second parameter data crosses the upper voltage threshold value. At this stage, it is determined that the ostomy appliance is in a second operating state.

At time around 45 h, curve 1104 shows that moisture is detected by the third electrode pair as the third parameter data crosses the upper voltage threshold value. At this stage, it is determined that the ostomy appliance is in a third operating state.

FIG. 14 shows an exemplary graphical representation of parameter data as a function of time. In this example, the parameter data in the y-axis is in Volts and time is in the x-axis. Curve 1202 shows, as a function of time, first parameter data indicative of voltage measured by the first electrode pair of the base plate. Curve 1204 shows, as a function of time, second parameter data indicative of voltage measured by the second electrode pair of the base plate. Curve 1200 shows, as a function of time, third parameter data indicative of voltage measured by the third electrode pair of the base plate. Curves 1206, 1208, 1210 show, as a function of time, fourth primary parameter indicative of voltage measured by the fourth electrode pair of the base plate, fourth secondary parameter indicative of voltage measured by the fourth electrode and the fifth electrode of the base plate, and fourth tertiary parameter indicative of voltage measured by the fifth electrode pair of the base plate respectively. Curves 1212, 1214, 1216 show, as a function of time, a gradient of fourth primary parameter indicative of voltage gradient measured by the fourth electrode pair of the base plate, a gradient of fourth secondary parameter indicative of voltage gradient measured by the fourth electrode and the fifth electrode of the base plate, and a gradient of fourth tertiary parameter indicative of voltage gradient measured by the fifth electrode pair of the base plate respectively. FIG. 14 shows the upper voltage threshold value represented as curve 1000, the medium voltage threshold value represented as curve 1002, the lower voltage threshold value represented as curve 1004, and curve 1006 represents a gradient limit.

Curves 1206, 1208, 1210 as well as curves 1212, 1214, 1216 show that moisture is detected at the proximal side of the first adhesive layer by the fourth electrode pair, the fourth and fifth electrode, and the fifth electrode pair at a time starting at 60 h until 90 h. As the three electrode pairs are triggered as shown by the decreases shown by 1206, 1208, 1210 and as the curves 1212, 1214, 1216 show a gradient below 80%, this is indicative of the presence of sweat at the proximal side of the first adhesive layer.

At a time of 30 min, curve 1202 shows that moisture is detected by the first electrode pair as the first parameter data crosses the upper voltage threshold value while curve 1204 shows that moisture is not detected by the second electrode pair as the second parameter data has not crossed the upper voltage threshold value. At this stage, it is determined that the ostomy appliance is in a first operating state.

At time around 40 h, curve 1204 shows that moisture is detected by the second electrode pair as the second parameter data crosses the upper voltage threshold value. At this stage, it is determined that the ostomy appliance is in a second operating state.

FIG. 15 shows an exemplary graphical representation of parameter data as a function of time. In this example, the parameter data in the y-axis is in Volts and time is in the x-axis. Curve 1300 shows, as a function of time, first parameter data indicative of voltage measured by the first electrode pair of the base plate. Curve 1302 shows, as a function of time, second parameter data indicative of voltage measured by the second electrode pair of the base plate. Curve 1304 shows, as a function of time, third parameter data indicative of voltage measured by the third electrode pair of the base plate. Curves 1306, 1308, 1310 show, as a function of time, fourth primary parameter indicative of voltage measured by the fourth electrode pair of the base plate, fourth secondary parameter indicative of voltage measured by the fourth electrode and the fifth electrode of the base plate, and fourth tertiary parameter indicative of voltage measured by the fifth electrode pair of the base plate respectively. Curves 1312, 1314, 1316 show, as a function of time, a gradient of fourth primary parameter indicative of voltage gradient measured by the fourth electrode pair of the base plate, a gradient of fourth secondary parameter indicative of voltage gradient measured by the fourth electrode and the fifth electrode of the base plate, and a gradient of fourth tertiary parameter indicative of voltage gradient measured by the fifth electrode pair of the base plate respectively. FIG. 15 shows the upper voltage threshold value represented as curve 1000, the medium voltage threshold value represented as curve 1002, the lower voltage threshold value represented as curve 1004, and curve 1006 is a gradient limit.

Curves 1306, 1308, 1310 as well as curves 1312, 1314, 1316 show that moisture is detected at the proximal side of the first adhesive layer by the fourth electrode pair at a time starting at around 25h. As leakage electrodes (i.e. the fourth electrode pair, the fourth and fifth electrode, and the fifth electrode pair) are trigger as shown by the decreases shown by 1306, 1308, 1310 and as curve 1312, 1314, 1316 show a gradient above 80%, this is indicative of the presence of output at the proximal side of the first adhesive layer. This indicate severe leakage. It may be determined that the ostomy appliance is in a sixth operating state.

At a time of 5 h, curve 1300 shows that moisture is detected by the first electrode pair as the first parameter data crosses the upper voltage threshold value while curve 1302 shows that moisture is not detected by the second electrode pair as the second parameter data has not crossed the upper voltage threshold value. At this stage, it is determined that the ostomy appliance is in a first operating state.

At time around 15 h, curve 1302 shows that moisture is detected by the second electrode pair as the second parameter data crosses the upper voltage threshold value. At this stage, it is determined that the ostomy appliance is in a second operating state.

At time around 30 h, curve 1304 shows that moisture is detected by the third electrode pair as the third parameter data crosses the upper voltage threshold value. In an example where the curves 1306, 1308, 1310 had not dropped below corresponding thresholds, curve 1304 indicates that moisture has reached the third electrode pair, and the present disclosure enables determining that the ostomy appliance is in a third operating state.

FIG. 16 shows an exemplary graphical representation of parameter data as a function of time and a whitening zone diameter (e.g. related to a radial thickness of a whitening ring surrounding the stomal opening) as a function of time. FIG. 16 illustrates the moisture propagation in the first adhesive layer as a function of time, and illustrates a correlation between parameter data detected by the first electrode pair and the second electrode pair of the base plate and actual moisture on the proximal surface of the first adhesive layer of the base plate. The actual moisture propagation in the first adhesive layer may appear as a whitening zone (e.g. a white ring around the stomal opening) in the first adhesive layer. Moisture affects the first adhesive layer in that the moisture reacts with the composition of the first adhesive layer to form the white ring around the stomal opening, and thereby reduces adhesive performance of the base plate. FIG. 16 is obtained by experiments where water is applied from the stomal opening of the based plate to follow, using the electrodes of the base plate, the radial propagation of moisture leading to radial erosion of the first adhesive layer of the base plate.

Curve 1502 shows, as a function of time, first parameter data indicative of voltage measured by the first electrode pair of the base plate. Curve 1504 shows, as a function of time, second parameter data indicative of voltage measured by the second electrode pair of the base plate. Curve 1506 shows a diameter of the white ring as a function of time. The first parameter data shows a decrease in e.g. voltage measured by the first electrode pair over time. It is also seen that the voltage of the second electrode pair drops at a later time than when the first parameter data shows a decrease in e.g. voltage dropped. This correlates well with the diameter of the white ring which goes from around 25-26 mm when the first electrode pair is triggered (e.g. first parameter data shows a decrease) to 38 mm when the second electrode pair is triggered (second parameter data shows a decrease). This corresponds substantially to the location of the first electrode pair at twice the first radial distance R1, and of the second electrode pair at twice the second radial distance R2.

It is noted that various regions and countries have various routines and recommendations to support optimal use of an ostomy appliance. For example, in regions of Europe, it may be indicated to the user that an ostomy appliance with a base plate as disclosed herein is an optimal state (corresponding to a first operating state) when the radial thickness of the whitening ring is between 0-15 mm (for a user not in compliance with a preferred use), such as between 0-7 mm (for a user in compliance with a preferred use), such as between 0-5 mm (recommended by a nurse).

For example, in Europe, it may be indicated to the user that an ostomy appliance with a base plate as disclosed herein is in suboptimal state (corresponding to a second operating state) and thereby indicate a consideration to change the base plate when the radial thickness of the whitening ring is such as between 5-10 mm (recommended by a nurse), between 7 mm and 10 mm (for a user in compliance with a preferred use), and/or between 15 mm and 30 mm (for a user not in compliance with a preferred use).

For example, in Europe, it may be indicated to the user that an ostomy appliance with a base plate as disclosed herein is in a poor state (corresponding to a third operating state) and indicate a request to change the base plate when the radial thickness of the whitening ring is more than 10 mm (recommended by a nurse), such as more than 15 mm (for a user in compliance with a preferred use), such as more than 30 mm (for a user not in compliance with a preferred use).

For example, in other regions (e.g. America), it may be indicated to the user that an ostomy appliance with a base plate as disclosed herein is an optimal state (corresponding to a first operating state) when the radial thickness of the whitening ring is between 0-20 mm (for a user not in compliance with a preferred use), such as between 0-10 mm (for a user in compliance with a preferred use), such as between 0-10 mm (recommended by a nurse).

For example, in other regions (e.g. America), it may be indicated to the user that an ostomy appliance with a base plate as disclosed herein is in suboptimal state (corresponding to a second operating state) and thereby indicate a consideration to change the base plate when the radial thickness of the whitening ring is such as between 10 mm and 20 mm (recommended by a nurse), between 10 mm and 20 (for a user in compliance with a preferred use), and/or between 20 mm and 40 mm (for a user not in compliance with a preferred use).

For example, in other regions (e.g. America), it may be indicated to the user that an ostomy appliance with a base plate as disclosed herein is in a poor state (corresponding to a third operating state) and indicate a request to change the base plate when the radial thickness of the whitening ring is more than 20 mm (recommended by a nurse), such as more than 20 mm (for a user in compliance with a preferred use), such as more than 40 mm (for a user not in compliance with a preferred use).

The disclosed methods, ostomy appliances, monitor devices, and accessory devices allow to accommodate the regional preferences of user in their use of the ostomy appliance so as to adjust thresholds for the operating states to the regional preference or use.

FIGS. 17A-17B shows exemplary graphical representations of peel force as a function of a peeling distance travelled by a peeling action exercising the peel force (e.g. perpendicularly to the proximal (or distal) surface of the first adhesive layer) on a first adhesive layer of a base plate disclosed herein. The peel force relates to a required force to peel the first adhesive layer off the skin surface. The peeling distance is with respect to one end of the first adhesive layer where the peel force starts to be exercised. The peeling distance relates to the size or length of the first adhesive layer and thereby may relate to a size or length of a portion the first adhesive layer affected by moisture and of a portion of the first adhesive layer not affected by moisture. The peel forces illustrated in FIGS. 17A-17B are representative of adhesive performance of the first adhesive layer of the base plate to the skin surface.

Composition of the first adhesive layer of the base plate as disclosed herein in one or more embodiments is formulated to provide adhesion of the base plate to the skin surface of the user when the base plate is worn and to maintain a dry and healthy skin surface. Avoiding maceration of skin when occluding the skin with an adhesive is done by transporting sweat away from the skin and into the first adhesive layer by means of e.g. hydrocolloid types and adhesive (e.g. hydrocolloid adhesives) forming part of an absorbing element of the first adhesive layer.

For example, when the absorbing element is in contact with moisture, (e.g. water, sweat, urine or faeces), the absorbing element absorb the moisture. This reduces the adhesion of the first adhesive layer to the skin.

For example, the first adhesive layer goes from a dry adhesive state with acceptable adhesive performance (e.g. acceptable adhesion and cohesion) in to a wet adhesive state (e.g. reduced or non-adhesion and low cohesion gel).

Curve 1602 of FIGS. 17A and 17B shows a peel force applied to the first adhesive layer as a function of a peeling distance travelled by a peeling action exercising the peel force on the first adhesive layer in a dry adhesive state, (e.g. not affected by moisture). The peel force is expressed in Newtons while the peeling distance is expressed in mm. The length of the first adhesive layer in dry adhesive state is illustrated by X5, corresponding to length of the first adhesive layer 1608 in dry adhesive state.

Curve 1602 shows that the peel force applied to the first adhesive layer in a dry adhesive state is equal to Y1 when the peeling distance is less than X1. At X1, the peeling force drops as the peeling distance increases towards X5 and the end of the first adhesive layer.

Curve 1604 of FIG. 17A shows a peel force applied to the first adhesive layer as a function of a peeling distance travelled by a peeling action exercising the peel force on the first adhesive layer in a wet adhesive state, (e.g. affected by moisture to the point of reaching a completely wet adhesive state, where the first adhesive layer has become a gel).

Curve 1604 shows that when the peeling distance is less than X2, the peel force applied to the first adhesive layer in a wet adhesive state is equal to Y2 which has much lower value than Y1. This shows that the adhesive performance of the first adhesive layer is reduced when the first adhesive layer is in a wet adhesive state. At X2, the peeling force drops as the peeling distance increases until the end of the first adhesive layer. It is noted that X2 is larger than X1, because the first adhesive layer in a wet adhesive state extends in volume, and thus in length due to the gelling of the components of the first adhesive layer.

The peel experiment illustrated in FIG. 17A shows a loss of adhesive performance when the first adhesive is in a wet adhesive state.

Curve 1606 of FIG. 17B shows a peel force applied to the first adhesive layer as a function of a peeling distance travelled by a peeling action exercising the peel force on the first adhesive layer illustrated 1610 which comprises a first portion 1610A in a dry adhesive state and a second portion 1610B in a wet adhesive state, (e.g. affected by moisture to the point of reaching a completely wet adhesive state, where the first adhesive layer has become a gel).

Curve 1606 shows that when the peeling distance is less than X3, the peel force applied to the first adhesive layer in a wet adhesive state is equal to Y3 which has lower value than Y1. This shows that the adhesive performance of the first adhesive layer is reduced when the first adhesive layer comprises a portion in a wet adhesive state. At X3, the peeling force drops as the peeling distance increases until the end of the first adhesive layer. It is noted that X3 corresponds to the length of the portion 1610A in dry adhesive state.

The peel experiment illustrated in FIG. 17B shows a loss of adhesive performance when the first adhesive is partly in a wet adhesive state.

Accordingly, FIGS. 17A-17B demonstrate that the operating state determined based on monitor data is indicative of adhesive performance of the base plate.

The use of the terms “first”, “second”, “third” and “fourth”, “primary”, “secondary”, “tertiary” etc. does not imply any particular order, but are included to identify individual elements.

Moreover, the use of the terms “first”, “second”, “third” and “fourth”, “primary”, “secondary”, “tertiary” etc. does not denote any order or importance, but rather the terms “first”, “second”, “third” and “fourth”, “primary”, “secondary”, “tertiary” etc. are used to distinguish one element from another. Note that the words “first”, “second”, “third” and “fourth”, “primary”, “secondary”, “tertiary” etc. are used here and elsewhere for labelling purposes only and are not intended to denote any specific spatial or temporal ordering. Furthermore, the labelling of a first element does not imply the presence of a second element and vice versa.

Although particular features have been shown and described, it will be understood that they are not intended to limit the claimed invention, and it will be made obvious to those skilled in the art that various changes and modifications may be made without departing from the spirit and scope of the claimed invention. The specification and drawings are, accordingly to be regarded in an illustrative rather than restrictive sense. The claimed invention is intended to cover all alternatives, modifications and equivalents.

LIST OF REFERENCES

-   1 ostomy system -   2 ostomy appliance -   4 base plate -   6 monitor device -   8 accessory device -   10 server device -   12 network -   14 coupling member -   16 coupling ring -   18, 18A, 18B, 18C, 18D stoma-receiving opening -   19 center of the opening -   20 docking station -   22 first connector -   24 user interface -   100 monitor device housing -   101 processor -   102 first interface -   104 second interface -   106 memory -   108 ground terminal of monitor device -   110 first terminal of monitor device -   112 second terminal of monitor device -   114 third terminal of monitor device -   116 fourth terminal of monitor device -   118 fifth terminal of monitor device -   120 coupling part -   121 power unit -   122 antenna -   123 transceiver -   124 wireless transceiver -   126 loudspeaker -   128 haptic feedback element -   130 transmission controller -   140 sensor unit -   200 first adhesive layer -   200A distal surface of first adhesive layer -   200B proximal surface of first adhesive layer -   202 second adhesive layer -   202A distal surface of second adhesive layer -   202B proximal surface of second adhesive layer -   204 electrode assembly -   204A distal surface of electrode assembly -   204B proximal surface of electrode assembly -   206 release liner -   206A distal surface of the release liner -   206B proximal surface of the release liner -   208 top layer -   208A distal surface of the top layer -   208B proximal surface of the top layer -   209 coupling ring -   210 coupling part of first connector -   211 first connector -   212 terminals of first connector -   213 first intermediate element -   213A distal surface of first intermediate element -   213B proximal surface of first intermediate element -   214 support layer of electrode assembly -   214A distal surface of support layer -   214B proximal surface of support layer -   216 electrodes of electrode assembly -   218 masking element -   218A distal surface of masking element -   218B proximal surface of masking element -   220 electrode configuration -   222 ground electrode -   222A ground connection part -   222B ground sensing part -   224 first electrode -   224A first connection part -   226 second electrode -   226A second connection part -   228 third electrode -   228A third connection part -   230 fourth electrode -   230A fourth connection part -   230B fourth sensing part -   232 fifth electrode -   232A fifth connection part -   232B fifth sensing part -   234 first electrode part of the ground electrode -   236 second electrode part of the ground electrode -   238 third electrode part of the ground electrode -   240 fourth electrode part of the ground electrode -   242 ground terminal opening -   244 first terminal opening -   246 second terminal opening -   248 third terminal opening -   250 fourth terminal opening -   252 fifth terminal opening -   254 primary sensor point openings of masking element -   254A primary first sensor point opening -   254B primary second sensor point opening -   256 secondary sensor point openings of masking element -   256A secondary first sensor point opening -   256B secondary second sensor point opening -   258 tertiary sensor point openings of masking element -   258A tertiary first sensor point opening -   258B tertiary second sensor point opening -   260 primary sensor point openings of first adhesive layer -   260A primary first sensor point opening -   260B primary second sensor point opening -   262 secondary sensor point openings of first adhesive layer -   262A secondary first sensor point opening -   262B secondary second sensor point opening -   264 tertiary sensor point openings of first adhesive layer -   264A tertiary first sensor point opening -   264B tertiary second sensor point opening -   282 ground terminal element

0282A ground terminal

-   284 first terminal element -   284A first terminal

0286 second terminal element

-   286A second terminal -   288 third terminal element -   288A third terminal -   290 fourth terminal element -   290A fourth terminal -   292 fifth terminal element -   292A fifth terminal -   300 method of monitoring an ostomy appliance with a monitor device -   301 obtaining monitor data based on ostomy data and/or parameter     data of the ostomy appliance -   302 controlling transmission of the monitor data according to a     transmission scheme -   302 a applying a primary transmission scheme or a secondary     transmission scheme different from the primary transmission scheme -   302 b determining the transmission scheme based on one or more     control parameters -   302 c determining a parameter data configuration and/or an ostomy     data configuration of the first transmission scheme based on the one     or more control parameters -   1000 curve representing the upper voltage threshold value -   1002 curve representing the medium voltage threshold value -   1004 curve representing the lower voltage threshold value -   1006 curve representing a gradient limit -   1100 curve showing, as a function of time, a first parameter data     indicative of voltage measured by the first electrode pair of the     base plate -   1102 curve showing, as a function of time, a second parameter data     indicative of voltage measured by the second electrode pair of the     base plate -   1104 curve showing, as a function of time, a third parameter data     indicative of voltage measured by the third electrode pair of the     base plate -   1108 curve showing, as a function of time, a fourth primary     parameter indicative of voltage measured by the fourth electrode     pair of the base plate -   1110 curve showing, as a function of time, a gradient of fourth     primary parameter indicative of voltage gradient -   1112 curve showing, as a function of time, a gradient of fourth     secondary parameter indicative of voltage gradient measured -   1114 curve showing, as a function of time, a gradient of fourth     tertiary parameter indicative of voltage gradient measured -   1116 curve showing, as a function of time, a fourth secondary     parameter indicative of voltage measured -   1118 curve showing, as a function of time, a fourth tertiary     parameter indicative of voltage measured

01200 curve showing, as a function of time, a third parameter data indicative of voltage measured by the third electrode pair of the base plate

-   1202 curve showing, as a function of time, a first parameter data     indicative of voltage measured by the first electrode pair of the     base plate -   1204 curve showing, as a function of time, a second parameter data     indicative of voltage measured by the second electrode pair of the     base plate -   1206 curve showing, as a function of time, a fourth primary     parameter indicative of voltage measured by the fourth electrode     pair of the base plate -   1208 curve showing, as a function of time, a fourth secondary     parameter indicative of voltage measured -   1210 curve showing, as a function of time, a fourth tertiary     parameter indicative of voltage measured -   1212 curve showing, as a function of time, a gradient of fourth     primary parameter indicative of voltage gradient measured by the     fourth electrode pair of the base plate -   1214 curve showing, as a function of time, a gradient of fourth     secondary parameter data indicative of voltage gradient measured -   1216 curve showing, as a function of time, a gradient of fourth     tertiary parameter indicative of voltage gradient measured -   1300 curve showing, as a function of time, a first parameter data     indicative of voltage measured by the first electrode pair of the     base plate -   1302 curve showing, as a function of time, a second parameter data     indicative of voltage measured by the second electrode pair of the     base plate -   1304 curve showing, as a function of time, a third parameter data     indicative of voltage measured by the third electrode pair of the     base plate -   1306 curve showing, as a function of time, a fourth primary     parameter indicative of voltage measured by the fourth electrode     pair of the base plate -   1308 curve showing, as a function of time, a fourth secondary     parameter indicative of voltage measured -   1310 curve showing, as a function of time, a fourth tertiary     parameter indicative of voltage measured -   1312 curve showing, as a function of time, a gradient of fourth     primary parameter indicative of voltage gradient measured by the     fourth electrode pair of the base plate -   1314 curve showing, as a function of time, a gradient of fourth     secondary parameter indicative of voltage gradient measured -   1316 curve showing, as a function of time, a gradient of fourth     tertiary parameter indicative of voltage gradient measured -   1502 curve showing, as a function of time, a first parameter data     indicative of voltage measured by the first electrode pair of the     base plate -   1504 curve showing, as a function of time, a second parameter data     indicative of voltage measured by the second electrode pair of the     base plate -   1506 curve showing a diameter of the white ring as a function of     time -   1602 curve showing peel force applied to the first adhesive layer in     a dry adhesive state as a function of peeling distance -   1604 a peel force applied to the first adhesive layer as a function     of a peeling distance travelled by a peeling action exercising the     peel force on the first adhesive layer in a wet adhesive state -   1606 a peel force applied to the first adhesive layer as a function     of a peeling distance travelled by a peeling action exercising the     peel force on the first adhesive layer partially wet -   1608 length of the first adhesive layer 1608 in dry adhesive state -   1610 the first adhesive layer which comprises a first portion in a     dry adhesive state and a second portion in a wet adhesive state -   1610A a first portion in a dry adhesive state -   1610B a second portion in a wet adhesive state 

1. A monitor device for a medical system, the monitor device comprising: a processor; memory; a first interface connected to the processor and the memory, the first interface configured for connecting to a base plate of a neducak appliance and for collecting data from the base plate; and a second interface comprising a transceiver connected to the processor for transmitting monitor data based on the data and/or parameter data of the base plate according to a transmission scheme, the second interface configured for connecting to one or more accessory devices, wherein the processor comprises a transmission controller configured to select the transmission scheme from a primary transmission scheme and a secondary transmission scheme based on one or more control parameters, the secondary transmission scheme being different from the primary transmission scheme.
 2. The monitor device according to claim 1, wherein the one or more control parameters comprises a control parameter indicative of an operating state of the medical appliance.
 3. The monitor device according to claim 1, wherein the one or more control parameters comprises a control parameter indicative of a power capacity of a power unit of the monitor device.
 4. The monitor device according to claim 1, wherein the one or more control parameters comprises a control parameter indicative of an appliance model of the medical appliance.
 5. The monitor device according to claim 1, wherein the one or more control parameters comprises a control parameter indicative of a data collection scheme of the monitor device.
 6. The monitor device according to claim 1, wherein the one or more control parameters comprise a control parameter indicative of a data processing scheme of the monitor device.
 7. The monitor device according to claim 1, wherein the one or more control parameters comprises a control parameter indicative of size of data and/or of the size of monitor data in the memory.
 8. The monitor device according to claim 1, wherein the one or more control parameters comprises a control parameter indicative of a wear time of the medical appliance.
 9. The monitor device according to claim 1, wherein the one or more control parameters comprises a control parameter indicative of preferences of a user of the medical appliance.
 10. The monitor device according to claim 1, wherein the one or more control parameters comprises a control parameter indicative of a location of a user of the medical appliance.
 11. The monitor device according to claim 1, wherein the one or more control parameters comprises a control parameter indicative of an activity level of a user.
 12. The monitor device according to claim 1, wherein the one or more control parameters comprises a control parameter indicative of connectivity between the monitor device and an accessory device.
 13. The monitor device according to claim 1, wherein the one or more control parameters comprises a control parameter indicative of a temperature of the monitor device and/or of the medical appliance.
 14. The monitor device according to claim 1, wherein the first transmission scheme comprises a first transmission parameter and the second transmission scheme comprises a second transmission parameter and wherein the first transmission parameter and the second transmission parameter are different.
 15. The monitor device according to claim 1, wherein the first transmission scheme comprises one or more criteria sets, each criteria set comprising one or more criteria to be applied in the first transmission scheme.
 16. The monitor device according to claim 1, wherein the first transmission scheme comprises a parameter data configuration indicative of parameter data to be transmitted in the first transmission scheme.
 17. The monitor device according to claim 1, wherein the first transmission scheme comprises an data configuration indicative of data to be transmitted in the first transmission scheme.
 18. The monitor device according to claim 1, wherein to control the transmission scheme comprises to determine a parameter data configuration and/or an data configuration of the first transmission scheme based on the one or more control parameters.
 19. A method of monitoring a medical appliance with a monitor device comprising a processor; memory; and a first interface connected to the processor and the memory, the first interface configured for connecting to a base plate of the medical appliance and for collecting data from the base plate; and a second interface configured for connecting to one or more accessory devices, the first interface comprising a plurality of terminals including a ground terminal and a first terminal, and the second interface comprising a transceiver connected to the processor for transmitting monitor data, the method comprising: obtaining monitor data based on data and/or parameter data of the base plate; and controlling transmission of the monitor data according to a transmission scheme, wherein controlling the transmission of the monitor data comprises selecting a transmission scheme from a primary transmission scheme and a secondary transmission scheme based on one or more control parameters, the secondary transmission scheme being different from the primary transmission scheme.
 20. A computer readable storage medium storing one or more programs, the one or more programs comprising instructions, which when executed by a monitor device with an interface, a memory and a processor cause the monitor device to be configured to operate in accordance with any one of claims 1-18.
 21. A medical appliance system comprising a medical appliance and a monitor device according to claim 1, the medical appliance comprising a base plate. 